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HOUSTON - Plus Therapeutics, Inc. (NASDAQ:PSTV) plans to begin commercial rollout of its CNSide cerebrospinal fluid diagnostic platform in the second half of 2025, according to a company statement released Thursday. The micro-cap company, currently valued at $16.12 million, has seen its stock surge over 55% in the past week, though InvestingPro analysis indicates the shares are trading above their Fair Value.
The CNSide platform, designed to diagnose and monitor central nervous system (CNS) cancer metastases, will initially launch in Texas before expanding to additional states in late 2025 and 2026. The company estimates the U.S. market opportunity for its first test, CNSide CSF Tumor Cell Enumeration, at over $6 billion. According to InvestingPro data, the company faces significant challenges with negative gross profit margins and rapidly depleting cash reserves. Get access to 12 more exclusive ProTips and comprehensive financial analysis with InvestingPro.
The diagnostic platform aims to address limitations in the current standard of care for CNS metastases diagnosis, which the company describes as offering "suboptimal test sensitivity." Plus Therapeutics claims the CNSide assay demonstrates 92% sensitivity and 95% specificity, citing eight peer-reviewed publications and real-world usage data from over 11,000 tests performed at more than 200 U.S. cancer institutions since 2020.
"The superior clinical utility of CNSide has been shown in 8 peer-reviewed publications, a completed clinical trial, and has been validated in the market through real-world use," the company stated.
Plus Therapeutics acquired CNSide in 2024 and has established a centralized testing laboratory in Houston. The company is pursuing state licensure, reimbursement codes, and payor coverage to support commercialization.
While the launch is on track for 2025, Plus Therapeutics CFO Andrew Sims indicated that "revenue contributions of the CNSide subsidiary will become meaningful to Plus Therapeutics’ operations in fiscal year 2026." This timeline is crucial as the company reported a significant revenue decline of 14.43% in the last twelve months, with analysts forecasting further sales decline this year. A detailed analysis of the company’s growth prospects is available in the comprehensive Pro Research Report on InvestingPro.
The company’s core business focuses on developing targeted radiotherapeutics for central nervous system cancers, including its lead candidate REYOBIQ for leptomeningeal metastases.
The information in this article is based on a press release from Plus Therapeutics.
In other recent news, Plus Therapeutics announced that the U.S. Food and Drug Administration has cleared its Investigational New Drug application for REYOBIQ, aimed at treating pediatric patients with high-grade glioma and ependymoma. This Phase 1/2a clinical trial, named ReSPECT-PBC, will be funded by a $3 million grant from the U.S. Department of Defense. The company has also restructured its $15 million equity financing to significantly reduce potential stock dilution, canceling warrants that could have led to the issuance of approximately 1.51 billion shares. In another development, Ascendiant Capital raised its price target for Plus Therapeutics to $20.50, maintaining a Buy rating, citing confidence in the company’s ongoing drug development. Financially, Plus Therapeutics reported $10 million in cash and no debt, with an additional $18 million raised in the first quarter, expected to sustain operations into 2026. Recent data from the ReSPECT-LM trial at a conference in Vienna demonstrated safety and clinical benefits for REYOBIQ in treating central nervous system cancers. The company also announced the appointment of Kyle Guse to its Board of Directors, where he will serve as the chair of the Audit Committee. Guse brings over 30 years of experience in financial and legal sectors, which Plus Therapeutics believes will aid in advancing its ambitious business plans.
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