Plus Therapeutics(PSTV) - 2025 Q2 - Quarterly Results

Plus Therapeutics Second Quarter 2025 Results Plus Therapeutics reported a Q2 2025 net income of $5.2 million, driven by REYOBIQ™ clinical progress and CNSide® diagnostic platform launch Management Commentary 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] - REYOBIQ™ clinical trials are showing favorable safety and efficacy signals, leading to active enrollment in the dose optimization trial[2] - 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] Q2 2025 & Recent Highlights and Milestones Q2 2025 milestones include equity restructuring, REYOBIQ™ clinical progress, and the CNSide® diagnostic platform commercial launch timeline 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] - 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] - Appointed industry veteran Kyle Guse to the Board of Directors[5] REYOBIQ™ Clinical Trials 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] - 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][6] - Presented updated interim data at the Nuclear Medicine and Neuro-oncology conference, highlighting the safety and clinical benefit of REYOBIQ™ in LM patients[5] CNSide® CSF Assay Platform 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] - The initial commercial focus will be on National Cancer Institute Designated Cancer Centers[9] - 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] Q2 2025 Financial Results 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] - Cash and investments balance increased to $6.9 million at June 30, 2025, from $3.6 million at December 31, 2024[9] Financial Statements The financial statements reflect the company's performance and position, including balance sheets, statements of operations, and cash flows Condensed Consolidated Balance Sheets 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 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 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 This section provides an overview of Plus Therapeutics, its lead radiotherapeutic REYOBIQ™, and its diagnostic platform CNSide® About Plus Therapeutics 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] About REYOBIQ (rhenium 186re obisbemeda) 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] - The ReSPECT-LM trial is funded by a $17.6M grant from the Cancer Prevention & Research Institute of Texas (CPRIT)[11] About CNSide Diagnostic, LLC 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] - The platform enables quantitative analysis and molecular characterization of tumor cells in cerebrospinal fluid (CSF)[12] Cautionary Statement Regarding Forward-Looking Statements This section outlines the forward-looking nature of statements in the press release and the inherent risks and uncertainties Forward-Looking Statements 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] - 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][16]