On March 12, 2026 Plus Therapeutics, Inc. (Nasdaq: PSTV) ("Plus" or the "Company"), a healthcare company developing and commercializing precision diagnostics and radiopharmaceuticals for central nervous system (CNS) cancers, reported financial results for the fourth quarter and year ended December 31, 2025 and provides an overview of recent and upcoming business highlights.
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"Our team remains highly focused on achieving our 2026 targets," said Marc H. Hedrick, M.D., Plus Therapeutics President and Chief Executive Officer. "Specifically, our top priority goals are CNSide commercial scale-up and REYOBIQ pivotal trial readiness; we also are looking aggressively for ways to over achieve where possible."
Q4 2025 AND RECENT HIGHLIGHTS
Corporate
Completed an upsized public offering generating $15 million in gross proceeds, extending the Company’s projected cash runway and supporting CNSide commercialization and advancement of two ongoing Phase 2 clinical programs
REYOBIQ Development
Secured American Medical Association Category III CPT reimbursement code for convection-enhanced delivery with REYOBIQ, unlocking market access and growth potential of REYOBIQ therapy in recurrent glioblastoma and pediatric brain cancer
Incorporating constructive Type B meeting feedback from the FDA to help accelerate clinical development timelines and facilitate submission of application for the approval of REYOBIQ for patients with leptomeningeal metastases (LM)
Highlighted three REYOBIQ clinical data presentations at the World Federation of Neuro-Oncology Societies/Society for Neuro-Oncology (WFNOS/SNO), building upon body of real world clinical experience with REYOBIQ in both primary and metastatic CNS cancers that continue to show promising safety profile and signs of efficacy
CNSide CSF Assay Platform
Expanded CNSide laboratory licensing to 49 of 50 U.S. states, having recently added Pennsylvania and California; enables access to CNSide Tumor Cell Enumeration (TCE) test to approximately 95% of the U.S. population
Continued to expand the CNSide Diagnostics team to support national test adoption
Announced second of planned national coverage agreements with Humana effective October 29, 2025. Combined with UnitedHealthcare national coverage agreement, CNSide CSF laboratory test policy coverage now reaches approximately 67 million people throughout the U.S.
Full Year 2025 FINANCIAL RESULTS
The Company’s cash and investments balance was $13.1 million on December 31, 2025 compared to $3.6 million on December 31, 2024
Recognized $5.2 million in grant revenue in the year ending December 31, 2025 and $5.8 million for the year ending December 31, 2024, which in both periods represents CPRIT’s share of the costs incurred for the advancement of our REYOBIQ development for the treatment of patients with LM
Total operating loss for the year ending December 31, 2025 was $15.3 million versus $14.7 million for the year ending December 31, 2024, with the increase primarily attributed to expansion of the CNSide operations team
Net loss for the year ending December 31, 2025 was $22.4 million, or $(0.29) per basic share versus $13.0 million, or $(1.95) per basic share, for the year ending December 31, 2024. The change in the net loss for the year ended December 31 was primarily due to change in fair value of derivative instruments from the Q1 2025 financings
Anticipated MILESTONES and OUTLOOK for 2026
REYOBIQ clinical program:
Define optimal dose/interval for REYOBIQ in the ReSPECT-LM Phase 2 trial; anticipate reporting data in Q3 2026
Completing enrollment in the ReSPECT-GBM Phase 2 trial for glioblastoma and conduct an End of Phase meeting with FDA with the goal of aligning on pivotal trial design. Data expected in Q4 2026
Complete commercial manufacturing scale up for REYOBIQ
Begin enrollment in the ReSPECT-PBC pediatric brain cancer Phase 1 trial
The Company expects research and development expenditures to increase in 2026 compared to 2025, due to increased costs for the ReSPECT-LM clinical trial, manufacturing scale up for REYOBIQ commercial and approval trial drug availability, and initial patient enrollments in the ReSPECT-PBC clinical trial, together with expansion of CNSide research and development teams.
CNSide commercial roll out:
Expand U.S. commercial payer coverage to >150 million covered lives
Secure Medicare coverage pathway
Achieve > 1,250 annualized test orders
Launch additional CSF tumor characterization assays to expand the CNSide platform
The Company expects general and administrative expenditures to increase in 2026 as compared to 2025 due to expanded CNSide commercial operations team (including sales, customer service and laboratory operations), such that the goal is for CNSide Diagnostics to breakeven by 2027.
About Leptomeningeal metastases (LM)
Leptomeningeal metastases (LM) are a rare but severe complication of advanced cancer, affecting the fluid-lined structures of the central nervous system. LM occurs in approximately 5% of patients with metastatic cancer, with breast cancer, lung cancer, and melanoma being the most common sources. Median survival is typically 2-6 months, and effective treatment options are limited, highlighting the urgent need for novel therapies.
About REYOBIQ (rhenium Re186 obisbemeda)
REYOBIQ (rhenium Re186 obisbemeda) is a novel injectable radiotherapy specifically formulated to deliver direct targeted high dose radiation in CNS tumors in a safe, effective, and convenient manner to optimize patient outcomes. REYOBIQ has the potential to reduce off target risks and improve outcomes for CNS cancer patients, versus currently approved therapies, with a more targeted and potent radiation dose. Rhenium-186 is an ideal radioisotope for CNS therapeutic applications due to its short half-life, beta energy for destroying cancerous tissue, and gamma energy for real-time imaging. REYOBIQ is being evaluated for the treatment of recurrent glioblastoma, leptomeningeal metastases, and pediatric brain cancer in the ReSPECT-GBM, ReSPECT-LM, and ReSPECT-PBC clinical trials. ReSPECT-GBM is supported by an award from the National Cancer Institute (NCI), part of the U.S. National Institutes of Health (NIH), and ReSPECT-LM is funded by a three-year $17.6M grant by the Cancer Prevention & Research Institute of Texas (CPRIT). The Company’s ReSPECT-PBC clinical trial for pediatric brain cancer is supported by a $3 million grant from the U.S. Department of Defense’s Peer Reviewed Cancer Research Program.
(Press release, Plus Therapeutics, MAR 12, 2026, View Source [SID1234663512])