Payment is part of $17.6 million award granted for leptomeningeal cancer targeted radiotherapeutic development programHOUSTON, July 23, 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, today announced that the Company received notice of an advance payment of $1.6 million from the Cancer Prevention and Research Institute of ...

Presentation by trial principal investigator at the 2025 SNO/ASCO CNS Metastases Conference Plus will also host an educational symposium with leading experts titled, “Reimagining Your Approach to Leptomeningeal Metastases” HOUSTON, July 15, 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, today announces the oral presentat ...

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, 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]

Core Viewpoint - Plus Therapeutics has initiated the ReSPECT-LM dose optimization trial for REYOBIQ™ to determine the optimal dosing schedule for treating leptomeningeal metastases, building on previous trial results and supported by a $17.6 million grant from CPRIT [1][7]. Trial Design and Objectives - The trial aims to optimize treatment dosing for maximum efficacy and safety, focusing on the safety and tolerability of multiple REYOBIQ doses administered via intraventricular catheter [2]. - Primary objectives include identifying the maximum tolerated dose and minimum effective dose for patients with LM from any primary solid tumor cancer [2]. Enrollment and Study Details - The trial will enroll up to 24 patients, evaluating REYOBIQ at a recommended Phase 2 dose of 44.1 mCi across three dosing intervals [4]. - Key cohorts include dosing intervals of 56 days, 28 days, and 14 days, with up to six patients per cohort [4]. Efficacy and Safety Data - Previous trials showed a clinical benefit rate of 76%, with 29% of patients achieving partial responses and 47% maintaining stable disease [5]. - No dose-limiting toxicities were observed in the first four cohorts, although one Grade 4 DLT occurred in each of Cohorts 5 and 6 [5]. Future Plans - The company plans to present data from the completed single-dose escalation trial at the SNO/ASCO CNS Metastases Conference in August 2025 and will request an End of Phase 1 Type B meeting with the FDA [6]. About Leptomeningeal Metastases - Leptomeningeal metastases occur in approximately 5% of patients with metastatic cancer, with median survival typically ranging from 2 to 6 months, highlighting the urgent need for effective treatment options [8]. About REYOBIQ™ - REYOBIQ™ is a novel injectable radiotherapy designed for targeted high-dose radiation in CNS tumors, with potential advantages over currently approved therapies [9]. Company Overview - Plus Therapeutics is a clinical-stage pharmaceutical company focused on developing targeted radiotherapeutics for challenging CNS cancers, with a pipeline that includes treatments for leptomeningeal metastases, recurrent glioblastoma, and pediatric brain cancer [10].

Summary of Plus Therapeutics (PSTV) Update - June 26, 2025 Company Overview - **Company**: Plus Therapeutics (PSTV) - **Focus**: CNS cancer diagnostics through the C Inside Diagnostics platform Key Industry Insights - **CNS Metastases**: Affects approximately 30% of all cancer patients, translating to over 1 million individuals in the US alone [6][14] - **Current Diagnostic Methods**: Outdated, with cytology dating back to 1904 and MRI from the 1970s, leading to inadequate diagnosis and treatment options [7] - **Market Opportunity**: Estimated total addressable market for CNS metastases diagnostics is approximately $6 billion in the US [14][35] Core Product Insights - **C Inside Diagnostics**: A comprehensive testing platform for CNS and CSF cancers, offering four tests from a single CSF sample with clinical specificity of 95% and sensitivity of 92% [8][11] - **Technological Advancements**: Capable of detecting tumor cells at a concentration of one cell per 5 ml of CSF, representing a significant improvement over existing methods [8] - **Regulatory Environment**: Operates under CMS regulations, exempt from FDA premarket review, facilitating a more predictable regulatory pathway [12][15] Acquisition and Business Strategy - **Acquisition Context**: C Inside was acquired in early 2024 as part of a distressed sale, with over $300 million previously invested in its development [5][11] - **Commercialization Plan**: Initial launch in Texas anticipated in Q3 2025, with plans for national expansion through 2027 [20][16] - **Testing Infrastructure**: Centralized lab in Houston, Texas, with plans for CMS accreditation expected in Q3 2025 [15][16] Financial and Market Projections - **Initial Market Traction**: Over 11,000 tests ordered by more than 200 physicians across 120 institutions since the initial launch in 2020 [11] - **Revenue Expectations**: Conservative forecasts for 2025 due to ongoing negotiations with payers and the need to re-establish agreements [18][21] - **Long-term Growth**: Anticipated meaningful revenue contributions from 2026 onwards as testing volumes increase [18] Reimbursement Strategy - **Value-Based Pricing**: Developing a pricing strategy based on clinical validation and market comparisons, aiming for favorable reimbursement decisions [26][27] - **Negotiation Status**: Engaged with previous payers and exploring new agreements, with a focus on establishing specific reimbursement codes [49][50] Future Expansion Plans - **International Opportunities**: While currently focused on the US market, there are considerations for international expansion in the future [57] Conclusion - **Market Need**: Addressing a significant unmet clinical need in CNS cancer diagnostics, with potential to improve patient outcomes and quality of life [19][35] - **Next Steps**: Continued communication with stakeholders as developments occur, with a focus on reintroducing C Inside to the market [60]

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]

Core Insights - Plus Therapeutics, Inc. is set to provide a business update on June 26, 2025, before the market opens, followed by a conference call and webcast at 9:00 a.m. ET [1] Company Overview - Plus Therapeutics is a clinical-stage pharmaceutical company based in Houston, Texas, focused on developing targeted radiotherapeutics for challenging central nervous system cancers [4] - The company aims to enhance clinical outcomes through a combination of image-guided local beta radiation and targeted drug delivery approaches [4] - Plus Therapeutics has a pipeline of product candidates, with lead programs targeting leptomeningeal metastases and recurrent glioblastoma [4] - The company has established a supply chain through strategic partnerships to support the development, manufacturing, and potential commercialization of its products [4]

Core Insights - Plus Therapeutics has received FDA clearance for its Investigational New Drug application for REYOBIQ, aimed at treating pediatric patients with high-grade glioma and ependymoma [2][5] - The Phase 1/2a trial, named ReSPECT-PBC, is supported by a $3 million grant from the U.S. Department of Defense and will focus on determining the maximum tolerated dose and safety of REYOBIQ in children aged 6 to 21 [1][4][7] Company Overview - Plus Therapeutics is a clinical-stage pharmaceutical company based in Houston, Texas, specializing in targeted radiotherapeutics for central nervous system cancers [9] - The company is advancing a pipeline that includes treatments for recurrent glioblastoma, leptomeningeal metastases, and pediatric brain cancer [9] Trial Design and Objectives - The ReSPECT-PBC trial is a two-part, single-arm study designed to assess the safety and tolerability of REYOBIQ, with a focus on pediatric patients with rare and aggressive brain tumors [4][7] - The trial will enroll approximately 56 patients, with 24 in Phase 1a for dose escalation and 32 in Phase 2a to assess efficacy [7] Treatment Potential - REYOBIQ is designed to deliver high doses of beta radiation directly to brain tumors while minimizing damage to surrounding healthy tissue, potentially improving outcomes for patients with limited treatment options [5][8] - The targeted delivery method via convection enhanced delivery (CED) aims to bypass the blood-brain barrier, which is a significant challenge in treating CNS tumors [4][5]

Core Insights - Plus Therapeutics has announced a comprehensive restructuring of its previous $15 million equity financing, which eliminates the potential issuance of up to 1.5 billion shares of common stock, aiming to enhance shareholder value and simplify its equity capital structure [1][6]. Company Overview - Plus Therapeutics, Inc. is a clinical-stage pharmaceutical company based in Houston, Texas, focused on developing targeted radiotherapeutics for challenging central nervous system cancers, with a pipeline that includes programs for leptomeningeal metastases and recurrent glioblastoma [4]. Restructuring Details - The restructuring involves the cancellation of approximately 25 million shares of common stock or pre-funded warrants, which will further reduce stockholder dilution [6]. - The company has filed a request with the SEC to withdraw the resale registration statement related to the March 2025 equity financing [3]. - Future financing provisions state that 90% of proceeds from any capital raised after July 1, 2025, will be used to repay holders of 22,727,270 shares of common stock at 115% of the original price paid, based on an effective initial price of $0.66 per share [6].