CNSide Diagnostics now licensed in 48 U.S. States covering over 90% of the U.S. populationHOUSTON, Dec. 11, 2025 (GLOBE NEWSWIRE) -- CNSide Diagnostics, LLC, a wholly-owned subsidiary of 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, announces that it has been granted lab licenses to provide the CNSide® Cerebrospinal Fluid (CSF) Tumor ...

Core Insights - Plus Therapeutics, Inc. has announced positive results from its RESPECT-LM Phase 1 clinical trial and has introduced the CNSide® CSF diagnostics platform with a national coverage agreement with UnitedHealthcare, covering over 51 million people in the U.S. [1][9] Corporate Overview - The company is focused on three main business verticals: diagnostics, therapeutics, and capital structure, with plans to expand its commercial team and footprint for CNSide [3] - Plus Therapeutics reported a cash and investments balance of $16.6 million as of September 30, 2025, a significant increase from $6.9 million on June 30, 2025, and $3.6 million on December 31, 2024 [7] - The company regained compliance with Nasdaq listing criteria, including market value and stockholder's equity thresholds [8] Clinical Trials and Product Development - Positive results from the ReSPECT-LM Phase 1 trial were presented, indicating that treatment of leptomeningeal metastases with REYOBIQ is feasible and shows promising efficacy [5] - The CNSide CSF assay platform demonstrated the ability to quantify leptomeningeal metastases over time and monitor changes in targetable mutations, potentially aiding in treatment initiation [9] Financial Performance - For Q3 2025, Plus Therapeutics reported a net loss of $4.4 million, or $0.04 per share, compared to a net loss of $2.9 million, or $0.37 per share, in Q3 2024 [15][21] - Total operating loss for Q3 2025 was $4.5 million, an increase from a loss of $3.8 million in the same quarter of 2024, primarily due to higher compensation and professional fees [15] Strategic Partnerships and Market Position - The company received an additional $1.9 million advance payment from the Cancer Prevention and Research Institute of Texas (CPRIT) as part of a previously awarded non-dilutive grant for cancer-targeted radiotherapeutics [8] - CNSide Diagnostics, a subsidiary of Plus Therapeutics, has made its CSF assay platform commercially available in Texas, focusing on National Cancer Institute Designated Cancer Centers [9][12]

Core Insights - Plus Therapeutics Inc. (NASDAQ:PSTV) experienced a significant stock price increase of 39.29% on Thursday, closing at $0.5630, following a national coverage agreement with UnitedHealth Group Inc. [1] Group 1: Partnership and Market Impact - The partnership allows Plus Therapeutics, through its subsidiary CNSide Diagnostics LLC, to provide CNSide Cerebrospinal Fluid Tumor Cell Enumeration laboratory developed tests (LDT) to over 51 million people in the US [2] - This agreement is expected to lead to increased revenues for both CNSide and Plus Therapeutics [3] Group 2: Product Performance and Efficacy - Since 2020, over 11,000 CNSide tests have been conducted at more than 120,000 cancer institutions, achieving a high sensitivity of 92% and specificity of 95%, while influencing treatment decisions in 90% of cases [4]

Core Insights - CNSide Diagnostics has received accreditation from CMS for its lab in Houston, Texas, meeting CLIA regulations, which is essential for testing human specimens [1][2] - This accreditation is a significant milestone in the company's strategy to expand access to the CNSide CSF assay platform for patients with CNS cancers [2] - The CNSide CSF Assay Platform is designed to identify tumor cells in cerebrospinal fluid, aiding in the management of patients with leptomeningeal metastases [3] Regulatory and Market Access - The certification ensures compliance with proficiency testing, personnel qualifications, and quality control, which are critical for market access [2][6] - Achieving this milestone is necessary for obtaining state licensure in 48 of 50 states and ensuring broad commercial insurance coverage [6] - Lab accreditation is mandatory for enrolling in Medicare and Medicaid programs, which is essential for receiving payments for testing services [6] Company Overview - CNSide Diagnostics is a subsidiary of Plus Therapeutics, focusing on developing proprietary tests for identifying tumor cells that have metastasized to the CNS [3] - Plus Therapeutics is a clinical-stage pharmaceutical company based in Houston, developing targeted radiotherapeutics for challenging CNS cancers [4] - The company is advancing a pipeline of product candidates, particularly in leptomeningeal metastases and recurrent glioblastoma [4]

Core Insights - Plus Therapeutics, Inc. is focused on developing targeted radiotherapeutics for central nervous system (CNS) cancers, with a particular emphasis on leptomeningeal metastases (LM) and recurrent glioblastoma (GBM) [5] - The company's subsidiary, CNSide Diagnostics, will present its CNSide Cerebrospinal Fluid (CSF) Assay Platform at the SNO/ASCO CNS Metastases Conference, showcasing its clinical utility in managing patients at risk for CNS metastases [1][2] Company Overview - Plus Therapeutics is a clinical-stage pharmaceutical company headquartered in Houston, Texas, developing advanced platform technologies for CNS cancers [5] - CNSide Diagnostics specializes in proprietary laboratory-developed tests to identify tumor cells that have metastasized to the CNS, enhancing patient management for those with leptomeningeal metastases [3] Industry Context - Leptomeningeal metastases occur in approximately 5% of patients with metastatic cancer, with breast cancer, lung cancer, and melanoma being the most common sources [4] - Median survival for patients with LM is typically between 2 to 6 months, indicating a significant need for novel therapeutic options [4]

Core Insights - Plus Therapeutics is set to launch its CNSide CSF Assay Platform in the U.S. market in the second half of 2025, targeting a significant unmet need in CNS cancer diagnostics with a market opportunity exceeding $6 billion [1][2][4] Company Overview - Plus Therapeutics, Inc. is a clinical-stage pharmaceutical company focused on developing targeted radiotherapeutics for central nervous system (CNS) cancers [14] - The company has invested over $300 million in the CNSide technology, which aims to address the clinical need for better diagnostic tools in CNS cancer [3] Product Details - The CNSide CSF Assay Platform is designed for patients suspected of having CNS cancer metastases, with the first test, CNSide CSF Tumor Cell Enumeration (TCE), expected to be commercialized soon [2][4] - The platform has demonstrated high sensitivity (92%) and specificity (95%) in diagnosing CNS metastases, influencing treatment decisions in 90% of cases [5] Market Opportunity - CNS metastases affect approximately 30% of adult cancer patients, and the current standard of care for diagnosis is outdated, leading to missed or delayed diagnoses [4] - The CNSide platform is positioned to provide superior clinical utility compared to the current standard of care, which has been validated through real-world use and peer-reviewed publications [5] Commercial Strategy - Plus Therapeutics has established a scalable testing laboratory in Houston, TX, and is executing a commercial market access strategy that includes state licensure and reimbursement codes [6][7] - The company anticipates launching the CNSide platform in Texas first, followed by expansion into additional states [6] Financial Outlook - The revenue contributions from the CNSide subsidiary are expected to become meaningful to Plus Therapeutics' operations in fiscal year 2026 [9]