Plus Therapeutics(US:PSTV)2025-08-14 20:12PART I. FINANCIAL INFORMATION This section provides the unaudited condensed consolidated financial statements and management's analysis of financial performance and liquidity Item 1. Consolidated Financial Statements (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 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 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 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 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 concern3132 - 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 2026343738 - 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 warrants96103 - 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 agreement126132 Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations Management discusses the company's radiotherapeutic pipeline, financial performance, liquidity challenges, and ongoing efforts to address Nasdaq listing compliance issues Overview and Pipeline 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 - The ReSPECT-GBM Phase 2 trial is expected to complete enrollment by the end of 2025, with a data readout also expected by year-end163 - 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 2025169173174 - 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 2025180181 - The company plans to re-introduce the acquired CNSide Test to the U.S. market starting in the second half of 2025149 Results of Operations 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 expense198 Liquidity and Capital Resources 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 doubt209 - 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)211214228 - 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 2025233235243 - 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 rule244 Item 3. Quantitative and Qualitative Disclosures about Market Risk 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 applicable261 Item 4. Controls and Procedures 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 report263 - 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 controls264 PART II. OTHER INFORMATION This section provides information on legal proceedings, risk factors, equity sales, and exhibits Item 1. Legal Proceedings The company reports that there are no legal proceedings to disclose for the period - The company reported no legal proceedings265 Item 1A. Risk Factors 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 Requirement267 - 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 requirement267273 - Delisting could lead to a decline in stock price, reduced liquidity, determination as a 'penny stock,' and a decreased ability to obtain future financing277282 Item 2. Unregistered Sales of Equity Securities and Use of Proceeds 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-K280 Item 6. Exhibits 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