Core Insights - Plus Therapeutics, Inc. is expanding its team at CNSide Diagnostics, LLC to enhance its capabilities in the CNS cancer diagnostics market, which is valued at over $6 billion in the U.S. [2][7] - The company is making progress towards a national launch and expanding test coverage, with plans for additional agreements with payors beyond existing contracts with UnitedHealthcare and Humana [2][8] Team Expansion - Mr. Prem Gurnani has been appointed as Senior Director of Lab Operations and Systems Implementation, bringing over 16 years of experience in diagnostics and clinical operations [8] - Ms. Elaine Luckey joins as Director of Quality and Regulatory Affairs, with over 20 years of experience in quality and regulatory affairs in laboratory environments [8] Equity Grants - The company granted stock options to Mr. Gurnani and Ms. Luckey, allowing them to purchase up to 33,750 shares each, with an exercise price equal to the closing stock price on December 4, 2025 [4][6] - Each executive also received 11,250 restricted stock units (RSUs), which will vest over three years, with one-third vesting on January 1, 2027 [5][6] Company Overview - Plus Therapeutics is a clinical-stage pharmaceutical company focused on developing targeted radiotherapeutics for challenging CNS cancers, aiming to improve clinical outcomes [8][9] - The company is advancing a pipeline of product candidates, particularly in leptomeningeal metastases and recurrent glioblastoma, supported by strategic partnerships for development and manufacturing [9]

Study findings to be featured in a poster spotlight presentationHOUSTON, Dec. 01, 2025 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV) (the “Company”), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system (CNS) cancers, announces the acceptance of an abstract for poster spotlight (with oral) presentation at the upcoming San Antonio Breast Cancer Symposium (SABCS), being held on December 9-12, 2025, in San Anto ...

Core Insights - Plus Therapeutics has completed a Type B meeting with the FDA to discuss clinical development plans for REYOBIQ targeting leptomeningeal metastases [1][2] - The company plans to provide an update on next steps early in 2026 and will implement amendments to the LM trial based on FDA recommendations [2] About Leptomeningeal Metastases (LM) - LM is a severe complication of advanced cancer, occurring in approximately 5% of metastatic cancer patients, with a median survival of 2-6 months [3] - Common sources of LM include breast cancer, lung cancer, and melanoma, highlighting the urgent need for novel therapies [3] About REYOBIQ™ - REYOBIQ is a novel injectable radiotherapy designed for targeted high-dose radiation in CNS tumors, potentially improving patient outcomes compared to existing therapies [4] - It is being evaluated in clinical trials for recurrent glioblastoma, leptomeningeal metastases, and pediatric brain cancer, with significant funding support from various institutions [4] About CNSide Diagnostic, LLC - CNSide Diagnostics, a subsidiary of Plus Therapeutics, develops proprietary tests to identify tumor cells in the CNS, aiding in the management of patients with leptomeningeal metastases [5] About Plus Therapeutics - Plus Therapeutics is a clinical-stage pharmaceutical company focused on developing targeted radiotherapeutics for CNS cancers, with a pipeline that includes programs for LM and recurrent glioblastoma [6] - The company has established a supply chain through strategic partnerships to support the development and potential commercialization of its products [6]

Core Insights - CNSide Diagnostics, LLC has signed a national agreement with Humana, Inc. to provide the CNSide Cerebrospinal Fluid Tumor Cell Enumeration laboratory developed test, covering approximately 16 million people in the U.S., increasing total policy coverage to 67 million people [1] - The CNSide CSF Assay Platform supports rapid diagnoses and treatment guidance for patients with leptomeningeal metastases, demonstrating superior clinical utility over standard care as evidenced by multiple peer-reviewed publications and real-world validation [2] - Since 2020, over 11,000 CNSide tests have been performed at more than 120 U.S. cancer institutions, achieving high sensitivity of 92% and specificity of 95%, influencing treatment decisions in 90% of cases [3] Company Overview - CNSide Diagnostics, LLC is a subsidiary of Plus Therapeutics, Inc., focused on developing proprietary laboratory-developed tests to identify tumor cells in patients with central nervous system metastases [4] - Plus Therapeutics, Inc. is a clinical-stage pharmaceutical company based in Houston, Texas, developing targeted radiotherapeutics for challenging cancers of the central nervous system, with a focus on leptomeningeal metastases and recurrent glioblastoma [5] - Humana, Inc. is dedicated to improving health outcomes for its customers through insurance and healthcare services, aiming to enhance the quality of life for various populations including those on Medicare and Medicaid [6]

Core Insights - Plus Therapeutics, Inc. is advancing novel treatments for leptomeningeal metastases (LM) with its products REYOBIQ™ and ReSPECT-LM, showcasing promising clinical trial results at upcoming conferences [1][2] Group 1: Company Overview - Plus Therapeutics is a clinical-stage pharmaceutical company focused on developing targeted radiotherapeutics for central nervous system (CNS) cancers [6] - The company is headquartered in Houston, Texas, and aims to enhance clinical outcomes through innovative therapies [6] Group 2: Product Information - REYOBIQ (rhenium Re186 obisbemeda) is an injectable radiotherapy designed for targeted high-dose radiation in CNS tumors, potentially improving patient outcomes compared to existing therapies [4] - REYOBIQ has received FDA Fast Track and Orphan Drug Designation, with ongoing enrollment in the ReSPECT-LM Dose Optimization Trial [2][4] Group 3: Clinical Trials and Results - The ReSPECT-LM Phase 1 trial demonstrated excellent tolerance of REYOBIQ at higher doses than current standards, indicating a broad therapeutic range [2] - Clinical benefit rate for REYOBIQ exceeded 75% across three relevant outcome measures, with no dose-limiting toxicities observed [6] Group 4: Market Need and Context - Leptomeningeal metastases occur in approximately 5% of metastatic cancer patients, with limited effective treatment options available, highlighting the urgent need for new therapies [3] - Median survival for patients with LM is typically between 2-6 months, underscoring the critical demand for innovative solutions [3]

Core Insights - Plus Therapeutics, Inc. is advancing its clinical-stage pharmaceutical initiatives focused on targeted radiotherapeutics for central nervous system (CNS) cancers, with significant progress in both clinical trials and diagnostic platform technologies [2][8] Corporate Highlights - The company completed a restructuring of a $15 million equity financing, simplifying its capital structure [6] - Plus Therapeutics received an advance payment of $1.6 million from the Cancer Prevention and Research Institute of Texas (CPRIT) as part of a previously awarded $17.6 million grant [6] - The company appointed Kyle Guse, an industry veteran with 30 years of experience, to its Board of Directors [6] - Plus Therapeutics presented updated interim data on its lead compound REYOBIQ™ at a conference, highlighting its safety and clinical benefits for patients with leptomeningeal metastases [6] Clinical Development - The REYOBIQ™ clinical trials are demonstrating favorable safety and efficacy signals, which are facilitating active enrollment in the dose optimization trial [2][4] - The company initiated the ReSPECT-LM dose optimization trial for REYOBIQ, treating the first two patients to evaluate multiple-dose regimens [6] - The U.S. Food and Drug Administration (FDA) cleared the Investigational New Drug (IND) application for REYOBIQ for pediatric patients with specific high-grade gliomas, supported by a $3 million grant from the Department of Defense [6] CNSide CSF Assay Platform - The CNSide CSF assay platform is set to launch in Texas, focusing initially on National Cancer Institute Designated Cancer Centers [10] - The total addressable market for the CNSide CSF Tumor Cell Enumeration (TCE) test is estimated to be $6 billion in the U.S., with plans to add three additional CNS assays [10] - The company aims to expand CNSide testing services regionally over the next 12 months [2][10] Financial Performance - As of June 30, 2025, the company reported cash and investments of $6.9 million, an increase from $3.6 million at the end of 2024 [10] - Grant revenue for Q2 2025 was $1.4 million, compared to $1.3 million in the same quarter of 2024 [10] - The total operating loss for Q2 2025 was $1.5 million, a decrease from $3.7 million in Q2 2024, attributed to improved operational cost control [10] - The company reported a net income of $5.2 million for Q2 2025, a significant turnaround from a net loss of $2.9 million in the same quarter the previous year [10]

Core Insights - Plus Therapeutics, Inc. announced positive data from a retrospective analysis of the CNSide CSF Assay Platform, which can quantify leptomeningeal metastases (LM) and monitor changes in targetable mutations over time [1][2] - The CNSide CSF Assay may catalyze the initiation of LM treatment and enable personalized cancer therapy by allowing real-time adaptation of treatment based on tumor biology [1][3] Company Overview - Plus Therapeutics is a clinical-stage pharmaceutical company focused on developing targeted radiotherapeutics for central nervous system cancers, with a pipeline that includes programs for leptomeningeal metastases and recurrent glioblastoma [6][7] - CNSide Diagnostics, LLC, a subsidiary of Plus Therapeutics, develops proprietary laboratory tests designed to identify tumor cells that have metastasized to the central nervous system [4] Research Findings - The analysis involved 613 CNSide assays ordered for 218 patients, with a significant majority (74%) being female and the most common cancers analyzed being breast (n=105) and lung (n=65) [2] - The CNSide CSF Assay demonstrated a diagnostic sensitivity 2.8 times greater than standard CSF cytology, influencing clinical management decisions in over 90% of LM cases [3][6] - The study found that 67% (412/613) of patients had detectable CSF tumor cells, with notable findings in patients undergoing multiple CSF draws [6] Clinical Implications - The CNSide CSF Assay can detect gene amplification in CSF tumor cells, providing therapeutic insights for targeting LM tumors [3] - Longitudinal analysis using CNSide may offer insights for modifying treatment strategies over time [3] Market Context - Leptomeningeal metastases occur in approximately 5% of patients with metastatic cancer, but postmortem studies suggest the frequency may be as high as 20%, indicating a need for more sensitive diagnostic options [5]

Core Insights - Plus Therapeutics, Inc. has received an advance payment of $1.6 million from the Cancer Prevention and Research Institute of Texas (CPRIT) as part of a $17.6 million grant for the development of targeted radiotherapeutics for leptomeningeal cancer [1][2] - The company expects to receive an additional $6 million in funding over the next 12 months, which will provide significant non-dilutive financing to support its clinical programs [2] - Plus Therapeutics is developing REYOBIQ™, a novel injectable radiotherapy aimed at treating CNS tumors, and is conducting clinical trials for recurrent glioblastoma, leptomeningeal metastases, and pediatric brain cancer [4][7] Funding and Financial Support - The funding from CPRIT, along with active grants from the NIH and DoD, reflects strong institutional support for Plus Therapeutics' clinical programs and enhances its capital position for long-term growth [2] - CPRIT is recognized as the second-largest public cancer research funder globally, with a mission to invest in cancer research and prevention initiatives in Texas [5] Clinical Development and Research - Leptomeningeal metastases (LM) occur in approximately 5% of patients with metastatic cancer, with limited effective treatment options available, highlighting the need for innovative therapies [3] - REYOBIQ is designed to deliver targeted high-dose radiation specifically to CNS tumors, potentially improving patient outcomes compared to existing therapies [4] - The CNSide diagnostic test is being developed to identify tumor cells that have metastasized to the central nervous system, which is crucial for managing patients with leptomeningeal metastases [6]

Core Insights - Plus Therapeutics is set to present the final results of its ReSPECT-LM clinical trial at the SNO/ASCO CNS Metastases Conference, highlighting the safety and efficacy of its treatment for leptomeningeal metastases [1][2] - The company will also host an educational symposium focusing on advancements in managing leptomeningeal metastases, featuring presentations from leading neuro-oncologists [3] Company Overview - Plus Therapeutics, Inc. is a clinical-stage pharmaceutical company based in Houston, Texas, specializing in targeted radiotherapeutics for central nervous system cancers [8] - The company is advancing a pipeline of product candidates, particularly in the areas of leptomeningeal metastases and recurrent glioblastoma, utilizing image-guided local beta radiation and targeted drug delivery [8] Product Information - REYOBIQ (rhenium Re186 obisbemeda) is a novel injectable radiotherapy developed by Plus Therapeutics, designed to deliver targeted high-dose radiation to CNS tumors [6] - REYOBIQ is currently being evaluated in clinical trials for recurrent glioblastoma, leptomeningeal metastases, and pediatric brain cancer, with significant funding support from various institutions [6] Industry Context - Leptomeningeal metastases are a severe complication of advanced cancer, occurring in approximately 5% of metastatic cancer patients, with limited effective treatment options available [5] - The median survival for patients with leptomeningeal metastases is typically between 2 to 6 months, underscoring the urgent need for novel therapies [5]

Core Insights - Plus Therapeutics, Inc. is advancing its ReSPECT-LM dose optimization trial for REYOBIQ, targeting leptomeningeal metastases (LM) with initial patient treatments underway [1][2] - The trial aims to identify optimal dosing regimens to maximize efficacy and safety, building on positive results from a previous Phase 1 study [3][4] - The company anticipates rapid enrollment due to the lack of FDA-approved therapies for LM and expects to complete Cohort 1 by the end of the year [2][4] Company Overview - Plus Therapeutics is a clinical-stage pharmaceutical company focused on developing targeted radiotherapeutics for central nervous system cancers [11] - The company’s lead product, REYOBIQ, is designed to deliver high-dose radiation directly to CNS tumors, potentially improving patient outcomes compared to existing therapies [8][11] - The ReSPECT-LM trial is supported by a $17.6 million grant from the Cancer Prevention & Research Institute of Texas (CPRIT), a significant funding source for cancer research [6][9] Clinical Trial Details - The ReSPECT-LM trial's primary objectives include determining the safety and tolerability of multiple REYOBIQ doses and identifying the maximum tolerated dose and minimum effective dose [3] - The previous Phase 1 trial demonstrated that a single dose of REYOBIQ could deliver an average absorbed dose of over 250 Gy, with significant tumor reduction observed in patients [4] - Data from the completed Phase 1 study will be presented at the upcoming SNO/ASCO CNS Metastases Conference in August 2025 [5] Industry Context - Leptomeningeal metastases occur in approximately 5% of patients with metastatic cancer, with limited treatment options available, highlighting the need for innovative therapies [7] - REYOBIQ is being evaluated for multiple indications, including recurrent glioblastoma and pediatric brain cancer, indicating a broad potential application in CNS oncology [8][9]