Core Insights - Plus Therapeutics, Inc. is a clinical-stage pharmaceutical company focused on developing targeted radiotherapeutics for central nervous system cancers [2] - The company will participate in the H.C. Wainwright 27th Annual Global Investment Conference from September 8 to 10, 2025 [1] - Dr. Marc H. Hedrick, President and CEO of Plus Therapeutics, will engage in a fireside chat at the conference, available on demand for registered investors starting September 5 [2] Company Overview - Plus Therapeutics is headquartered in Houston, Texas, and specializes in targeted radiotherapeutics aimed at difficult-to-treat CNS cancers [2] - The company is advancing a pipeline of product candidates, with lead programs targeting leptomeningeal metastases and recurrent glioblastoma [2] - Plus Therapeutics has established a supply chain through strategic partnerships to support the development, manufacturing, and potential commercialization of its products [2]

Core Points - Plus Therapeutics, Inc. has confirmed compliance with Nasdaq Listing Rule 5550(b), meeting both the Market Value of Listing Securities (MVLS) standard of at least $35 million and the stockholders' equity threshold of at least $2.5 million [1][2] - Nasdaq has granted Plus Therapeutics an extension until November 12, 2025, to regain compliance with the $1.00 bid price rule, previously set for September 8, 2025 [2] - The company is under a one-year monitoring period for the Equity Standard, which will last until August 22, 2026, during which it must maintain compliance to avoid delisting [3] Company Overview - Plus Therapeutics is a clinical-stage pharmaceutical company based in Houston, Texas, focused on developing targeted radiotherapeutics for central nervous system cancers [4] - The company employs advanced technologies combining image-guided local beta radiation and targeted drug delivery, with key programs targeting leptomeningeal metastases and recurrent glioblastoma [4] - Plus Therapeutics has established a supply chain through strategic partnerships to support the development, manufacturing, and potential commercialization of its products [4]

Core Insights - Plus Therapeutics, Inc. announced positive data from the ReSPECT-LM Phase 1 trial, demonstrating a clinical benefit rate of over 75% in three relevant outcome measures for the treatment of leptomeningeal metastases with REYOBIQ [1][2] - The trial showed no dose-limiting toxicities and an overall favorable safety profile, indicating the treatment is feasible and effective [1][4] Study Details - The Phase 1 trial involved 29 subjects across six cohorts receiving varying doses of REYOBIQ, ranging from 6.6 mCi to 75 mCi [2] - Early cohorts exhibited excellent tolerance at higher doses, supporting a broad therapeutic range [4] Efficacy and Safety - The study reported a radiographic response rate of 76% and a clinical response rate of 87% through day 112 [6] - CSF tumor cell enumeration assays showed a maximum reduction of 100% at day 28, with a median overall survival of 9 months across the first four cohorts, which is significantly better than the typical 2-6 months reported in literature [6] Future Directions - The trial results provide a foundation for moving into ongoing dosing optimization and potential approval trials [4] - REYOBIQ is being evaluated for multiple CNS cancers, including recurrent glioblastoma and pediatric brain cancer, with significant funding support from the National Cancer Institute and the Cancer Prevention & Research Institute of Texas [5][7]

Core Points - Plus Therapeutics, Inc. reported stockholders' equity of $3 million as of June 30, 2025, satisfying Nasdaq Listing Rule 5550(b)(1) [1][4] - The company was previously notified on June 3, 2025, that it no longer met the Equity Rule as of March 31, 2025, leading to a delist determination [2] - Following a hearing on July 15, 2025, the Nasdaq Hearings Panel granted an extension for the company to demonstrate compliance with the Equity Rule [3] Company Overview - Plus Therapeutics is a clinical-stage pharmaceutical company based in Houston, Texas, focused on developing targeted radiotherapeutics for central nervous system cancers [5] - The company utilizes image-guided local beta radiation and targeted drug delivery methods, with lead programs addressing leptomeningeal metastases and recurrent glioblastoma [5] - Plus Therapeutics has established a supply chain through strategic partnerships to support the development, manufacturing, and potential commercialization of its products [5]

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]

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]