Plus Therapeutics Reports 2025 Financial Results, Business Progress, and 2026 Outlook

HOUSTON, Texas, March 12, 2026 – Plus Therapeutics, Inc. (Nasdaq: PSTV), a clinical-stage pharmaceutical company specializing in radiotherapeutics for central nervous system (CNS) cancers, has released its financial results for the fourth quarter and full year ended December 31, 2025. The company also provided a comprehensive update on its business progress and key milestones anticipated for 2026, with a primary focus on the CNSide® commercial launch and REYOBIQ™ pivotal trial readiness.

Key Corporate and Business Highlights

• Successful Public Offering: Plus Therapeutics completed an upsized public offering, raising \$15 million in gross proceeds. This has significantly extended the company’s projected cash runway and will fund both the commercialization of CNSide and ongoing Phase 2 clinical programs.
• Cash Position Improvement: The company’s cash and investments rose to \$13.1 million as of December 31, 2025, compared to \$3.6 million at the end of 2024.
• Expansion of CNSide Diagnostics: CNSide laboratory licensing now covers 49 out of 50 U.S. states, including recent additions of Pennsylvania and California, enabling access to 95% of the U.S. population. Coverage agreements now include both Humana and UnitedHealthcare, reaching approximately 67 million lives.

REYOBIQ™ Clinical Program and Regulatory Progress

• CPT Reimbursement Code Secured: The American Medical Association has granted a Category III CPT reimbursement code for convection-enhanced delivery with REYOBIQ, unlocking market access and growth potential in recurrent glioblastoma and pediatric brain cancer.
• FDA Feedback and Clinical Acceleration: The company is incorporating constructive Type B meeting feedback from the FDA to accelerate clinical development and facilitate a regulatory submission for REYOBIQ in leptomeningeal metastases (LM).
• Clinical Data Presentations: Three REYOBIQ data presentations were featured at the World Federation of Neuro-Oncology Societies/Society for Neuro-Oncology (WFNOS/SNO) meeting, reinforcing a growing body of real-world clinical experience with REYOBIQ in both primary and metastatic CNS cancers, with ongoing promising safety and efficacy signals.

CNSide CSF Assay Platform Commercialization

• Team Expansion: The CNSide Diagnostics team has grown to support national adoption of the CNSide Tumor Cell Enumeration (TCE) test.
• Coverage Milestones: National coverage agreements with major insurers now enable policy coverage for approximately 67 million people, with plans to expand further in 2026.

2025 Financial Performance

• Grant Revenue: \$5.2 million recognized in 2025, representing CPRIT’s (Cancer Prevention & Research Institute of Texas) share of REYOBIQ development costs for LM treatment.
• Total Operating Loss: \$15.3 million in 2025, up from \$14.7 million in 2024, primarily due to the expansion of CNSide operations.
• Net Loss: \$22.4 million, or \$(0.29) per basic share, versus \$13.0 million, or \$(1.95) per share in 2024. The year-over-year increase was mainly driven by changes in the fair value of derivative instruments from Q1 2025 financings.

2026 Anticipated Milestones and Outlook

REYOBIQ Clinical Program

• Define optimal dosing and interval in the ReSPECT-LM Phase 2 trial, with data expected in Q3 2026.
• Complete enrollment in the ReSPECT-GBM Phase 2 trial for glioblastoma and conduct an End of Phase meeting with the FDA to align on pivotal trial design; data expected in Q4 2026.
• Complete commercial manufacturing scale-up for REYOBIQ.
• Initiate enrollment in the ReSPECT-PBC (pediatric brain cancer) Phase 1 trial.
• R&D expenditures are expected to increase due to higher costs for ongoing and new clinical trials, manufacturing scale-up, and the expansion of CNSide research and development teams.

CNSide Commercial Rollout

• Expand U.S. commercial payer coverage to over 150 million covered lives.
• Secure Medicare coverage pathway for CNSide diagnostics.
• Achieve more than 1,250 annualized test orders.
• Launch additional CSF tumor characterization assays to grow the CNSide platform.
• General and administrative expenses are expected to rise due to expanded commercial operations, with a target for CNSide Diagnostics to reach breakeven by 2027.

Product and Pipeline Overview

Leptomeningeal Metastases (LM)

LM is a serious complication of advanced cancer, affecting the fluid-lined structures of the CNS, and occurs in about 5% of patients with metastatic cancer. Median survival is just 2-6 months, underscoring the urgent unmet need for novel therapies.

REYOBIQ™ (rhenium Re186 obisbemeda)

• An innovative injectable radiotherapy designed to deliver direct, targeted, high-dose radiation to CNS tumors, aiming to improve outcomes and reduce off-target risks versus existing therapies.
• Rhenium-186 offers an optimal profile for CNS applications, with a short half-life, effective beta energy for tumor destruction, and gamma energy for real-time imaging.
• REYOBIQ is being evaluated in the ReSPECT-GBM, ReSPECT-LM, and ReSPECT-PBC trials, supported by grants from the National Cancer Institute, CPRIT (\$17.6 million), and the U.S. Department of Defense (\$3 million for pediatric brain cancer).

CNSide Diagnostics, LLC

• Develops and commercializes laboratory-developed tests such as CNSide®, enabling quantitative analysis of cerebrospinal fluid to guide management of leptomeningeal metastases.

Balance Sheet and Liquidity

• Current assets as of December 31, 2025: \$15.2 million, up from \$5.3 million in 2024.
• Total assets: \$16.3 million (2025) vs. \$6.6 million (2024).
• Total liabilities: \$12.3 million (2025) compared to \$15.6 million (2024), showing improved financial health.
• Stockholders’ equity turned positive at \$4.0 million in 2025 from a deficit of \$8.9 million in 2024, largely due to capital raises and reduced liabilities.

Potential Price-Sensitive and Shareholder-Relevant Information

• Significant Capital Raise: The successful \$15 million public offering strengthens the company’s cash position, supporting ongoing operations and strategic flexibility.
• Expanded Insurance Coverage: New coverage agreements with major insurers and increased state licensing for CNSide could drive substantial revenue growth and wider market adoption.
• Regulatory and Clinical Progress: Securing a CPT reimbursement code and positive FDA feedback for REYOBIQ may significantly de-risk regulatory pathways and unlock future commercial potential.
• Pipeline Milestones: Multiple data readouts and regulatory interactions planned for 2026 could serve as major catalysts for the share price, especially if clinical results are positive.
• Profitability Outlook: The company is targeting CNSide Diagnostics to break even by 2027, signaling a move toward financial sustainability.

Risks and Forward-Looking Statements

The report contains forward-looking statements regarding clinical development, regulatory approval, commercialization, and financial expectations. Risks include the early stage of product candidates, the need for additional capital, regulatory and market uncertainties, manufacturing challenges, and reliance on third-party partners and insurers.

Conclusion

Plus Therapeutics’ 2025 results and 2026 outlook reveal meaningful progress in clinical development, insurance coverage, and financial footing, alongside several potential share price catalysts in the coming year. However, investors should remain aware of significant risks inherent in the company’s stage of development and evolving regulatory landscape.

Disclaimer: This article is for informational purposes only and does not constitute investment advice. Investors should review official filings and consult with their financial advisors before making any investment decisions. The information is based on company disclosures and may contain forward-looking statements subject to risks and uncertainties.

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