Plus Therapeutics (PSTV -5.80%), a clinical-stage biotech focused on radiotherapeutics and diagnostics for central nervous system cancers, reported its second quarter 2025 results on August 14, 2025. The company posted a significant turnaround in GAAP net income, moving from a $(2.9) million loss in Q2 2024 to a $5.2 million profit, though this was driven primarily by a nonrecurring $6.5 million fair value adjustment related to derivative instruments. GAAP revenue grew to $1.4 million compared to $1.3 million in the same quarter of 2024, just below the $1.49 million GAAP consensus estimate. GAAP earnings per share was $0.02, beating expectations by $0.11 (GAAP EPS). GAAP operating losses narrowed compared to Q2 2024. While overall results reflected cost discipline and pipeline progress, the core business remains reliant on grant revenue, and product sales have yet to begin.
| Metric | Q2 2025 | Q2 2025 Estimate | Q2 2024 | Y/Y Change |
|---|---|---|---|---|
| EPS (GAAP) | $0.02 | $(0.09) | $(0.45) | $0.47 |
| Revenue (GAAP) | $1.4 million | $1.49 million | $1.3 million | 7.7% |
| Operating Loss | $(1.5 million) | $(3.7 million) | Narrowed | |
| Net Income (Loss) | $5.2 million | $(2.9 million) | N/A | |
| Cash and Investments (end of period) | $6.9 million | N/A |
Source: Analyst estimates for the quarter provided by FactSet.
Business Overview and Recent Strategic Focus
Plus Therapeutics develops radiotherapeutic medicines and diagnostic assays aimed at treating cancers that affect the central nervous system, such as glioblastoma and leptomeningeal metastases. The company's primary asset is REYOBIQ, a patented radiotherapy delivered directly into the central nervous system. The pipeline also includes the CNSide diagnostic platform designed to deliver more sensitive detection of tumor cells in spinal fluid.
The company's recent focus areas center around advancing REYOBIQ through clinical trial milestones and positioning CNSide for initial commercial launch. Plus Therapeutics' success hinges on its ability to progress drug candidates through trials, achieve regulatory approvals, secure funding, and demonstrate adoption of its diagnostics in clinical settings. Partnerships, such as the collaboration with NanoTx, Corp. for glioblastoma treatments, are also pivotal to the strategy.
Quarter in Review: Financial and Operational Developments
The period saw a sharp jump in GAAP net income, which reached $5.2 million. This reversal from the previous year's net loss was not due to core business improvement but stemmed from a nonrecurring $6.5 million gain on the revaluation of financial derivatives (GAAP). Core results remain unprofitable, with a GAAP operating loss of $(1.5) million. Revenue came entirely from grant funding, mostly from the Cancer Prevention and Research Institute of Texas, and not from product sales or services. Grant revenue rose by 8.6% to $1.4 million compared to $1.3 million in Q2 2024, but this trailed analyst expectations by $0.086 million (GAAP revenue).
The company reported lower operating costs, with total GAAP operating expenses falling by 41% compared to Q2 2024, a potential sign of progressing clinical milestones and cost control measures. General and administrative costs decreased by 24% compared to Q2 2024 as management tightened spending. The cash and investments position at quarter-end improved to $6.9 million, supported by capital restructuring, grant advances, and reduced liabilities. This provides more financial flexibility.
On the product side, the company achieved several pipeline milestones. The REYOBIQ radiotherapy advanced in its ReSPECT-LM clinical trial, with the first patients enrolled for dose optimization targeting leptomeningeal metastases. Interim data from prior updates continue to indicate favorable safety and efficacy, though the U.S. Food and Drug Administration cleared an Investigational New Drug application for pediatric trial use, funded by a $3 million grant from the Department of Defense. The company highlighted upcoming data presentations at a key cancer conference in August.
The CNSide diagnostic platform, which tests cerebrospinal fluid for tumor cells, is set to launch commercially in Texas in August 2025. The initial test, CSF Tumor Cell Enumeration, will target a large addressable U.S. market estimated at $6 billion. There are plans to introduce three additional assays in the months ahead and to expand geographically in 2026. Early adoption, billing, and real-world testing outcomes will be crucial for measuring future revenue impact. No product revenue has yet been recognized, and all current income is from grant sources.
Strategically, Plus Therapeutics simplified its capital structure through restructuring a $15 million financing, reducing debt by eliminating a line of credit, and adding a biopharma executive to its board. As a result, assets rose as of June 30, 2025 compared to December 31, 2024, and Current liabilities (GAAP) fell by more than half, from $15.6 million at December 31, 2024 to $7.3 million at June 30, 2025. The company received a $1.6 million grant prepayment to support clinical trial work, reinforcing its reliance on external funding in the absence of commercial income.
Looking Ahead: Outlook and Key Watch Points
Management did not provide specific financial guidance for the next quarter or for fiscal 2025. Instead, it emphasized near-term priorities, including the CNSide launch in Texas, continued clinical trial enrollment and advancement for REYOBIQ, and a broadening suite of diagnostic tests targeting underserved markets. Investors should pay close attention to the company’s ability to convert CNSide’s launch into actual revenue, accelerate clinical trial progress, and manage cash given its current operating burn rate of roughly $1.5 million per quarter (GAAP operating loss).
Watch for updates on product sales, clinical data, grant funding, and any new capital raising.
Revenue and net income presented using U.S. generally accepted accounting principles (GAAP) unless otherwise noted.
