Plus Therapeutics(PSTV) - 2024 Q4 - Annual Results

Plus Therapeutics Q4 and Full Year 2024 Report Plus Therapeutics' Q4 and full year 2024 report details financial results, strategic financing, advancements in REYOBIQ and CNSide programs, and upcoming milestones Q4 2024 & Recent Highlights and Milestones In Q4 2024 and early 2025, Plus Therapeutics secured $15.0 million in financing, extending its operational runway into 2026 and regaining Nasdaq compliance. The company advanced its lead drug, REYOBIQ, with FDA brand name approval, Orphan Drug Designation for leptomeningeal metastases (LM), and positive Phase 1 data publication. Its diagnostic platform, CNSide, also showed positive utility data, with a full commercial launch planned for 2025. Key leadership appointments were made to support these developments Corporate Highlights Corporate highlights include securing $15.0 million in financing, obtaining a $2.0 million grant advance, and strengthening the management team with key appointments - Raised $15.0 million in a private placement, extending the company's financial runway into 2026 and ensuring compliance with Nasdaq's minimum stockholders' equity requirement[5] - Obtained a $2.0 million grant advance from its existing $17.6 million CPRIT grant to accelerate the development of REYOBIQ for leptomeningeal metastases (LM)[5] - Strengthened the management team with key appointments: Dr. Michael Rosol as Chief Development Officer, Mr. Russell Bradley as President and GM of CNSide Diagnostics, and Dr. Jonathan Stein as Medical Director for CNSide Diagnostics[5] REYOBIQ Program Highlights REYOBIQ program highlights include FDA brand name approval, positive Phase 1 data publication, Orphan Drug Designation for LM, and completion of the ReSPECT-LM Phase 1 trial - Received U.S. FDA agreement for the brand name REYOBIQ (Rhenium Re 186 Obisbemeda)[5] - Published Phase 1 results for recurrent glioblastoma (GBM) in Nature Communications, showing a median overall survival of 17 months for patients receiving a radiation dose >100 Gy, more than double the standard of care[5] - Granted U.S. FDA Orphan Drug Designation for REYOBIQ for treating LM in lung cancer patients[5] - Completed the ReSPECT-LM Phase 1 single-dose trial and determined the recommended Phase 2 dose[8] - Expanded strategic agreement with Telix IsoTherapeutics Group to ensure a reliable supply of cGMP Rhenium-186 for late-stage trials and commercialization[8] CNSide Diagnostic Platform Highlights CNSide diagnostic platform highlights include positive clinical trial data presentation and the planned full commercial launch in 2025 - Presented positive data from the FORESEE clinical trial and real-world studies, demonstrating the utility of the CNSide assay platform in diagnosing and managing patients with LM[8] - The full commercial launch of the CNSide diagnostic platform is on track for 2025, which is expected to make Plus Therapeutics an operational revenue-generating company[2][8] Upcoming Expected Events and Milestones The company anticipates a series of key milestones in 2025, including presentations at major medical conferences, completion of enrollment for multiple clinical trials (ReSPECT-LM and ReSPECT-GBM), an end-of-Phase 1 meeting with the FDA for the ReSPECT-LM trial, and obtaining IND approval for a new pediatric brain cancer trial (ReSPECT-PBC) in the second half of the year - Key upcoming milestones for 2025 include: * Presentations at the NMN Symposium (May 2025) and SNO/ASCO CNS Metastases Conference (August 2025) * Complete enrollment of Cohort 1 in the ReSPECT-LM Phase 1 multiple dose trial * Complete end-of-Phase 1 meeting with the U.S. FDA for the ReSPECT-LM trial * Complete ReSPECT-GBM Phase 2 enrollment * Obtain IND approval for the ReSPECT-PBC Phase 1/2 trial for pediatric brain tumors in H2 2025[8] Full Year 2024 Financial Results Summary For the full year 2024, Plus Therapeutics reported grant revenue of $5.8 million, an increase from $4.9 million in 2023. The operating loss widened to $14.7 million from $13.3 million year-over-year, primarily due to increased R&D expenses for the ReSPECT-LM trial. The net loss was $13.0 million, or $(1.95) per share, compared to a net loss of $13.3 million, or $(4.24) per share, in 2023. The company's cash and investments stood at $3.6 million at year-end Full Year 2024 vs. 2023 Financial Highlights | Financial Metric | 2024 | 2023 | | :--- | :--- | :--- | | Grant Revenue | $5.8 million | $4.9 million | | Operating Loss | $14.7 million | $13.3 million | | Net Loss | $13.0 million | $13.3 million | | Net Loss Per Share (basic) | $(1.95) | $(4.24) | | Cash and Investments (at Dec 31) | $3.6 million | $8.6 million | Company Overview Plus Therapeutics, Inc. is a Houston-based clinical-stage pharmaceutical company focused on developing targeted radiotherapeutics for difficult-to-treat central nervous system (CNS) cancers, with lead programs in leptomeningeal metastases (LM) and recurrent glioblastoma (GBM). Its wholly owned subsidiary, CNSide Diagnostics, LLC, is developing and commercializing laboratory tests like CNSide™ to detect and characterize tumor cells in the cerebrospinal fluid, with a planned U.S. launch in 2025 - Plus Therapeutics is a clinical-stage pharmaceutical company developing targeted radiotherapeutics for CNS cancers, combining image-guided local beta radiation with targeted drug delivery[11] - CNSide Diagnostics, a wholly owned subsidiary, develops and commercializes proprietary tests to identify tumor cells that have metastasized to the CNS. Its CNSide™ platform is planned for commercialization in the U.S. in 2025[12] Financial Statements This section presents the company's consolidated financial statements, including balance sheets, statements of operations, and statements of cash flows Consolidated Balance Sheets The consolidated balance sheets present the company's financial position, including assets, liabilities, and stockholders' equity, as of December 31, 2024 and 2023 Consolidated Balance Sheets (in thousands) | As of December 31, | 2024 | 2023 | | :--- | :--- | :--- | | Assets | | | | Cash and cash equivalents | $ 76 | $ 8,554 | | Investments | $ 3,530 | $ — | | Total current assets | $ 5,259 | $ 9,834 | | Total assets | $ 6,633 | $ 11,388 | | Liabilities and Stockholders' Equity (Deficit) | | | | Total current liabilities | $ 15,551 | $ 10,727 | | Total liabilities | $ 15,582 | $ 12,736 | | Total stockholders' equity (deficit) | $ (8,949) | $ (1,348) | | Total liabilities and stockholders' equity (deficit) | $ 6,633 | $ 11,388 | Consolidated Statements of Operations The consolidated statements of operations detail the company's revenues, expenses, and net loss for the years ended December 31, 2024 and 2023 Consolidated Statements of Operations (in thousands, except per share data) | For the Years Ended December 31, | 2024 | 2023 | | :--- | :--- | :--- | | Grant revenue | $ 5,824 | $ 4,913 | | Research and development | $ 10,580 | $ 9,690 | | General and administrative | $ 9,939 | $ 8,544 | | Total operating expenses | $ 20,519 | $ 18,234 | | Operating loss | $ (14,695) | $ (13,321) | | Net loss | $ (12,978) | $ (13,316) | | Net loss per share of common stock - basic | $ (1.95) | $ (4.24) | | Weighted average number of shares outstanding - basic | 6,640,251 | 3,140,925 | Consolidated Statements of Cash Flows The consolidated statements of cash flows summarize the company's cash inflows and outflows from operating, investing, and financing activities for 2024 and 2023 Consolidated Statements of Cash Flows (in thousands) | For the Years Ended December 31, | 2024 | 2023 | | :--- | :--- | :--- | | Net cash used in operating activities | $ (10,554) | $ (12,851) | | Net cash used in investing activities | $ (4,111) | $ (160) | | Net cash provided by financing activities | $ 6,187 | $ 3,445 | | Net decrease in cash and cash equivalents | $ (8,478) | $ (9,566) | | Cash and cash equivalents at end of period | $ 76 | $ 8,554 |