Company Performance - Plus Therapeutics reported a quarterly loss of $0.01 per share, outperforming the Zacks Consensus Estimate of a loss of $0.09, and showing improvement from a loss of $0.71 per share a year ago, resulting in an earnings surprise of +88.89% [1] - The company posted revenues of $1.39 million for the quarter ended June 2025, missing the Zacks Consensus Estimate by 18.24%, but showing an increase from year-ago revenues of $1.28 million [2] - Over the last four quarters, Plus has surpassed consensus EPS estimates only once and has topped consensus revenue estimates just once [2] Stock Performance - Plus shares have declined approximately 50.1% since the beginning of the year, contrasting with the S&P 500's gain of 10% [3] - The current consensus EPS estimate for the upcoming quarter is -$0.08 on revenues of $2.21 million, and for the current fiscal year, it is -$0.55 on revenues of $7.16 million [7] Industry Outlook - The Medical - Drugs industry, to which Plus belongs, is currently ranked in the top 35% of over 250 Zacks industries, indicating a favorable outlook compared to the bottom 50% [8]

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]

[PART I. FINANCIAL INFORMATION](index=5&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) This section provides the unaudited condensed consolidated financial statements and management's analysis of financial performance and liquidity [Item 1. Consolidated Financial Statements (Unaudited)](index=5&type=section&id=Item%201.%20Consolidated%20Financial%20Statements%20(Unaudited)) The unaudited consolidated financial statements detail the company's financial position, operational results, and cash flows, highlighting a net loss and going concern risk [Condensed Consolidated Balance Sheets](index=5&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) The balance sheets show increased total assets to $10.35 million and a shift to positive stockholders' equity of $3.03 million by June 30, 2025 Condensed Consolidated Balance Sheet Highlights (in thousands) | Financial Item | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $2,233 | $76 | | Total current assets | $9,214 | $5,259 | | Total assets | $10,350 | $6,633 | | **Liabilities & Equity** | | | | Total current liabilities | $7,316 | $15,551 | | Total liabilities | $7,316 | $15,582 | | Total stockholders' equity (deficit) | $3,034 | $(8,949) | [Condensed Consolidated Statements of Operations](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) The statements of operations reveal a net loss of $12.25 million for the six months ended June 30, 2025, driven by increased financing costs despite reduced operating expenses Condensed Consolidated Statements of Operations (in thousands) | Metric | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | | Grant revenue | $2,449 | $2,956 | | Research and development | $3,002 | $5,536 | | General and administrative | $4,521 | $4,416 | | Operating loss | $(5,074) | $(6,996) | | Net income (loss) | $(12,250) | $(6,201) | | Net income (loss) per share – basic | $(0.50) | $(1.15) | [Condensed Consolidated Statements of Cash Flows](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Cash flow statements show a net increase in cash of $2.2 million, primarily from $15.2 million in financing activities, offsetting increased cash used in operations Condensed Consolidated Statements of Cash Flows Highlights (in thousands) | Cash Flow Activity | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(11,970) | $(5,663) | | Net cash used in investing activities | $(1,074) | $(4,166) | | Net cash provided by financing activities | $15,201 | $6,187 | | **Net increase (decrease) in cash** | **$2,157** | **$(3,642)** | [Notes to Condensed Consolidated Financial Statements](index=9&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) The notes detail critical accounting policies, liquidity concerns, Nasdaq compliance issues, and complex financing transactions, including derivative liabilities - The company incurred a net loss of **$12.3 million** for the six months ended June 30, 2025, and had an accumulated deficit of **$505.7 million**, raising substantial doubt about its ability to continue as a going concern[31](index=31&type=chunk)[32](index=32&type=chunk) - The company has faced multiple Nasdaq compliance notices for failing to meet the Minimum Stockholders' Equity Requirement and the Minimum Bid Price Requirement, and is subject to a Mandatory Panel Monitor until March 2026[34](index=34&type=chunk)[37](index=37&type=chunk)[38](index=38&type=chunk) - In March 2025, the company completed a private placement raising approximately **$15.0 million** in gross proceeds through the issuance of common stock, pre-funded warrants, and Series A and B warrants[96](index=96&type=chunk)[103](index=103&type=chunk) - On June 17, 2025, the company entered into a purchase agreement with Lincoln Park Capital Fund for up to **$50.0 million** of common stock, and by June 30, 2025, had already raised approximately **$2.8 million** from this agreement[126](index=126&type=chunk)[132](index=132&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=26&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's radiotherapeutic pipeline, financial performance, liquidity challenges, and ongoing efforts to address Nasdaq listing compliance issues [Overview and Pipeline](index=26&type=section&id=Overview%20and%20Pipeline) This section outlines the company's focus on developing radiotherapeutics for CNS cancers, highlighting clinical trial progress for REYOBIQ and the re-launch of the CNSide diagnostic platform - Lead radiotherapeutic candidate REYOBIQ is being developed for recurrent glioblastoma (GBM), leptomeningeal metastases (LM), and pediatric brain cancers (PBC)[148](index=148&type=chunk) - The ReSPECT-GBM Phase 2 trial is expected to complete enrollment by the end of 2025, with a data readout also expected by year-end[163](index=163&type=chunk) - The ReSPECT-LM Phase 1 trial was completed in February 2025, determining a recommended Phase 2 dose. A dose optimization trial was initiated in June 2025[169](index=169&type=chunk)[173](index=173&type=chunk)[174](index=174&type=chunk) - The FDA cleared the IND for REYOBIQ for pediatric brain cancer in June 2025, with the Phase 1/2a ReSPECT-PBC trial expected to begin enrollment in 2025[180](index=180&type=chunk)[181](index=181&type=chunk) - The company plans to re-introduce the acquired CNSide Test to the U.S. market starting in the second half of 2025[149](index=149&type=chunk) [Results of Operations](index=36&type=section&id=Results%20of%20Operations) Operating results show decreased grant revenue and R&D expenses, but increased financing costs led to a higher net loss for the six months ended June 30, 2025 Comparison of Operating Results (in thousands) | Item | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | Change | | :--- | :--- | :--- | :--- | | Grant Revenue | $2,449 | $2,956 | $(507) | | Research & Development Expenses | $3,002 | $5,536 | $(2,534) | | General & Administrative Expenses | $4,521 | $4,416 | $105 | - The decrease in R&D expenses for the six months ended June 30, 2025, was primarily due to a **$1.2 million** reduction in clinical expenses and a **$0.8 million** decrease in compensation expense[198](index=198&type=chunk) [Liquidity and Capital Resources](index=38&type=section&id=Liquidity%20and%20Capital%20Resources) Liquidity remains a concern due to recurring losses, necessitating significant capital raises and ongoing efforts to maintain Nasdaq listing compliance - The company has an accumulated deficit of **$505.7 million** as of June 30, 2025, and its ability to continue as a going concern is in substantial doubt[209](index=209&type=chunk) - Key financing events in 2025 include the February 2025 SPEA, the March 2025 Private Placement (gross proceeds of ~**$15.0M**), and the June 2025 Lincoln Park Purchase Agreement (up to **$50.0M**)[211](index=211&type=chunk)[214](index=214&type=chunk)[228](index=228&type=chunk) - The company regained compliance with Nasdaq's Minimum Stockholders' Equity Requirement in March 2025 but fell out of compliance again as of March 31, 2025. It also received a notice for failing the Minimum Bid Requirement in May 2025[233](index=233&type=chunk)[235](index=235&type=chunk)[243](index=243&type=chunk) - A Nasdaq panel granted the company until August 14, 2025, to demonstrate compliance with the stockholders' equity rule and until September 8, 2025, for the minimum bid price rule[244](index=244&type=chunk) [Item 3. Quantitative and Qualitative Disclosures about Market Risk](index=39&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) The company states that this item is not applicable, indicating it does not have significant exposure to market risk - The company has determined that quantitative and qualitative disclosures about market risk are not applicable[261](index=261&type=chunk) [Item 4. Controls and Procedures](index=39&type=section&id=Item%204.%20Controls%20and%20Procedures) Management, including the CEO and CFO, evaluated the company's disclosure controls and procedures and concluded they were effective at a reasonable assurance level as of June 30, 2025 - The CEO and CFO concluded that the company's disclosure controls and procedures were effective as of the end of the period covered by the report[263](index=263&type=chunk) - There were no changes in internal control over financial reporting during the quarter ended June 30, 2025, that materially affected, or are reasonably likely to materially affect, internal controls[264](index=264&type=chunk) [PART II. OTHER INFORMATION](index=40&type=section&id=PART%20II.%20OTHER%20INFORMATION) This section provides information on legal proceedings, risk factors, equity sales, and exhibits [Item 1. Legal Proceedings](index=40&type=section&id=Item%201.%20Legal%20Proceedings) The company reports that there are no legal proceedings to disclose for the period - The company reported no legal proceedings[265](index=265&type=chunk) [Item 1A. Risk Factors](index=40&type=section&id=Item%201A.%20Risk%20Factors) The primary risk factor is potential Nasdaq delisting due to non-compliance with minimum stockholders' equity and bid price requirements, which could severely impact liquidity and financing - The company is at risk of being delisted from Nasdaq for failing to meet the Minimum Stockholders' Equity Requirement and the Minimum Bid Requirement[267](index=267&type=chunk) - A Nasdaq panel has given the company until August 14, 2025, to comply with the equity requirement and until September 8, 2025, to comply with the bid price requirement[267](index=267&type=chunk)[273](index=273&type=chunk) - Delisting could lead to a decline in stock price, reduced liquidity, determination as a 'penny stock,' and a decreased ability to obtain future financing[277](index=277&type=chunk)[282](index=282&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=41&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) Information regarding unregistered sales of equity securities during the quarter has been previously disclosed in the company's Current Reports on Form 8-K filed with the SEC - All unregistered sales of equity securities during the reporting period have been previously reported on Form 8-K[280](index=280&type=chunk) [Item 6. Exhibits](index=43&type=section&id=Item%206.%20Exhibits) This section provides an index of all exhibits filed with or incorporated by reference into the Form 10-Q, including corporate governance documents, descriptions of securities, material contracts, and officer certifications

[Plus Therapeutics Second Quarter 2025 Results](index=1&type=section&id=Plus%20Therapeutics%20Second%20Quarter%202025%20Results) Plus Therapeutics reported a Q2 2025 net income of $5.2 million, driven by REYOBIQ™ clinical progress and CNSide® diagnostic platform launch [Management Commentary](index=1&type=section&id=Management%20Commentary) The CEO highlighted steady execution on key strategic initiatives, advancing REYOBIQ™ clinical development and CNSide® commercialization - The company is focused on two key strategic initiatives: the clinical development of its radiotherapeutic (REYOBIQ™) and the commercialization of its diagnostic platform technologies (CNSide®)[2](index=2&type=chunk) - REYOBIQ™ clinical trials are showing favorable safety and efficacy signals, leading to active enrollment in the dose optimization trial[2](index=2&type=chunk) - The CNSide® CSF assay platform is set to launch in Texas, with plans to expand its availability over the next 12 months to meet clinical demand[2](index=2&type=chunk) [Q2 2025 & Recent Highlights and Milestones](index=1&type=section&id=Q2%202025%20%26%20Recent%20Highlights%20and%20Milestones) Q2 2025 milestones include equity restructuring, REYOBIQ™ clinical progress, and the CNSide® diagnostic platform commercial launch timeline [Corporate](index=1&type=section&id=Corporate) The company completed equity financing restructuring, received a $1.6 million grant advance, and appointed a new board member - Completed a comprehensive restructuring of the March 2025 **$15 million equity financing** to simplify the capital structure[5](index=5&type=chunk) - Received a **$1.6 million advance payment** from the Cancer Prevention and Research Institute of Texas (CPRIT) as part of a larger **$17.6 million grant**[5](index=5&type=chunk) - Appointed industry veteran Kyle Guse to the Board of Directors[5](index=5&type=chunk) [REYOBIQ™ Clinical Trials](index=1&type=section&id=REYOBIQ%E2%84%A2%20Clinical%20Trials) The company initiated a new REYOBIQ™ dose optimization trial, received FDA clearance for a pediatric IND, and presented updated interim data - Initiated the ReSPECT-LM dose optimization trial for REYOBIQ™ in patients with leptomeningeal metastases (LM) and treated the first two patients[5](index=5&type=chunk) - Received FDA clearance for its Investigational New Drug (IND) application for REYOBIQ™ to treat pediatric patients with high-grade glioma (HGG) and ependymoma, funded by a **$3 million Department of Defense grant**[5](index=5&type=chunk)[6](index=6&type=chunk) - Presented updated interim data at the Nuclear Medicine and Neuro-oncology conference, highlighting the safety and clinical benefit of REYOBIQ™ in LM patients[5](index=5&type=chunk) [CNSide® CSF Assay Platform](index=2&type=section&id=CNSide%C2%AE%20CSF%20Assay%20Platform) The CNSide® CSF assay platform will be commercially available in Texas starting August 2025, targeting NCI-designated cancer centers - The CNSide® CSF assay platform and testing services will be commercially available in Texas starting **August 2025**[9](index=9&type=chunk) - The initial commercial focus will be on National Cancer Institute Designated Cancer Centers[9](index=9&type=chunk) - The first test to be commercialized, CNSide CSF Tumor Cell Enumeration (TCE), has an estimated total addressable market of **$6 billion in the U.S.**[9](index=9&type=chunk) [Q2 2025 Financial Results](index=2&type=section&id=Q2%202025%20Financial%20Results) Plus Therapeutics reported a Q2 2025 net income of $5.2 million, a turnaround from a $2.9 million net loss, primarily due to derivative instrument fair value changes Q2 2025 Financial Performance | Financial Metric | Q2 2025 | Q2 2024 | | :--- | :--- | :--- | | Grant Revenue | $1.4 million | $1.3 million | | Total Operating Loss | $1.5 million | $3.7 million | | Net Income (Loss) | $5.2 million | $(2.9) million | | Net Income (Loss) Per Share | $0.02 | $(0.45) | - The substantial shift from a net loss to net income was primarily due to a **$6.5 million pre-tax income** from the change in the fair value of derivative instruments[9](index=9&type=chunk) - Cash and investments balance increased to **$6.9 million** at June 30, 2025, from **$3.6 million** at December 31, 2024[9](index=9&type=chunk) [Financial Statements](index=5&type=section&id=Financial%20Statements) The financial statements reflect the company's performance and position, including balance sheets, statements of operations, and cash flows [Condensed Consolidated Balance Sheets](index=5&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) As of June 30, 2025, total assets increased to $10.4 million, liabilities decreased to $7.3 million, and stockholders' equity turned positive to $3.0 million Condensed Consolidated Balance Sheets (in thousands) | Balance Sheet Item (in thousands) | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Cash and cash equivalents | $2,233 | $76 | | Total current assets | $9,214 | $5,259 | | **Total assets** | **$10,350** | **$6,633** | | Total current liabilities | $7,316 | $15,551 | | **Total liabilities** | **$7,316** | **$15,582** | | **Total stockholders' equity (deficit)** | **$3,034** | **$(8,949)** | [Condensed Consolidated Statements of Operations](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) For Q2 2025, the company reported a net income of $5.2 million, improving from a $2.9 million net loss in 2024, primarily due to a $6.5 million gain from derivative instruments Condensed Consolidated Statements of Operations (in thousands) | Statement of Operations (in thousands) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | | :--- | :--- | :--- | | Grant revenue | $1,390 | $1,279 | | Research and development | $1,246 | $2,773 | | General and administrative | $1,682 | $2,203 | | **Operating loss** | **$(1,538)** | **$(3,697)** | | Change in fair value of derivative instruments | $6,512 | $4,694 | | **Net income (loss)** | **$5,151** | **$(2,940)** | | **Net income (loss) per share – basic** | **$0.02** | **$(0.45)** | [Condensed Consolidated Statements of Cash Flows](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) For the six months ended June 30, 2025, net cash used in operating and investing activities was offset by $15.2 million from financing, leading to a $2.2 million net cash increase Condensed Consolidated Statements of Cash Flows (in thousands) | Cash Flow Summary (in thousands) | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(11,970) | $(5,663) | | Net cash used in investing activities | $(1,074) | $(4,166) | | Net cash provided by financing activities | $15,201 | $6,187 | | **Net increase (decrease) in cash** | **$2,157** | **$(3,642)** | | **Cash and cash equivalents at end of period** | **$2,233** | **$4,912** | [Company and Product Overview](index=3&type=section&id=Company%20and%20Product%20Overview) This section provides an overview of Plus Therapeutics, its lead radiotherapeutic REYOBIQ™, and its diagnostic platform CNSide® [About Plus Therapeutics](index=3&type=section&id=About%20Plus%20Therapeutics) Plus Therapeutics, Inc. is a clinical-stage pharmaceutical company developing targeted radiotherapeutics for difficult-to-treat central nervous system cancers - The company develops targeted radiotherapeutics for CNS cancers, combining image-guided local beta radiation with targeted drug delivery[10](index=10&type=chunk) [About REYOBIQ (rhenium 186re obisbemeda)](index=3&type=section&id=About%20REYOBIQ%20(rhenium%20186re%20obisbemeda)) REYOBIQ is an injectable radiotherapy using Rhenium-186 to deliver targeted high-dose radiation directly to CNS tumors, currently in clinical trials - REYOBIQ is a novel injectable radiotherapy using Rhenium-186 to deliver targeted high-dose radiation to CNS tumors[11](index=11&type=chunk) - The ReSPECT-LM trial is funded by a **$17.6M grant** from the Cancer Prevention & Research Institute of Texas (CPRIT)[11](index=11&type=chunk) [About CNSide Diagnostic, LLC](index=3&type=section&id=About%20CNSide%20Diagnostic%2C%20LLC) CNSide Diagnostics develops and commercializes laboratory tests to identify and quantitatively analyze tumor cells metastasized to the central nervous system - CNSide develops proprietary laboratory tests to identify tumor cells that have metastasized to the CNS[12](index=12&type=chunk) - The platform enables quantitative analysis and molecular characterization of tumor cells in cerebrospinal fluid (CSF)[12](index=12&type=chunk) [Cautionary Statement Regarding Forward-Looking Statements](index=3&type=section&id=Cautionary%20Statement%20Regarding%20Forward-Looking%20Statements) This section outlines the forward-looking nature of statements in the press release and the inherent risks and uncertainties [Forward-Looking Statements](index=3&type=section&id=Forward-Looking%20Statements) This press release contains forward-looking statements regarding clinical trials, operations, and future performance, subject to inherent risks and uncertainties - Statements in the press release regarding clinical trials, expected operations, and future developments are considered forward-looking[13](index=13&type=chunk) - Key risks include the early stage of product candidates, clinical trial uncertainties, liquidity and capital resources, regulatory hurdles, and challenges with radiotherapeutic manufacturing and distribution[15](index=15&type=chunk)[16](index=16&type=chunk)

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]

Table of Contents As filed with the Securities and Exchange Commission on August 12, 2025. Registration No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form S-1 REGISTRATION STATEMENT Under The Securities Act of 1933 PLUS THERAPEUTICS, INC. (Exact name of Registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) Delaware 2834 33-0827593 (Primary Standard Industrial Classification Code Number) (I.R.S. Employer Identification Number ...

Core Insights - Plus Therapeutics, Inc. is set to launch its CNSide cerebrospinal fluid (CSF) assay platform and testing services in Texas by August 2025, focusing initially on NCI-Designated Cancer Centers and large private healthcare systems [2][9] - The CNSide assay is designed to diagnose and monitor leptomeningeal metastases (LM), a severe complication of advanced cancer, with a high sensitivity of 92% and specificity of 95% [6][7] - The company has conducted over 11,000 CNSide tests at more than 200 U.S. cancer institutions since 2020, demonstrating significant clinical utility and influencing treatment decisions in over 90% of cases [6][8] Company Overview - Plus Therapeutics, Inc. is a clinical-stage pharmaceutical company headquartered in Houston, Texas, focusing on developing targeted radiotherapeutics for difficult-to-treat CNS cancers [9] - CNSide Diagnostics, LLC, a wholly-owned subsidiary of Plus Therapeutics, develops proprietary laboratory tests to identify tumor cells that have metastasized to the CNS [8] - The CNSide CSF Assay Platform enables quantitative analysis and molecular characterization of tumor cells and circulating tumor DNA, improving patient management for those with LM [8] Market Context - Leptomeningeal metastases occur in approximately 5% of patients with metastatic cancer, with median survival typically ranging from 2 to 6 months, indicating a critical need for effective diagnostic tools and therapies [7] - The current standard of care, CSF cytology, has suboptimal sensitivity, leading to missed or delayed diagnoses, which CNSide aims to address with its advanced testing capabilities [6][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 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]