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HOUSTON - Plus Therapeutics, Inc. (NASDAQ:PSTV), a micro-cap biotech company with a market capitalization of $15.33 million, has treated its first patients in the ReSPECT-LM dose optimization trial for REYOBIQ (rhenium Re186 obisbemeda) targeting leptomeningeal metastases (LM), the company announced Tuesday. According to InvestingPro data, the company maintains a stronger cash position than debt, though it’s currently experiencing rapid cash burn as it advances its clinical programs.
The trial builds on the company’s completed Phase 1 single-dose escalation study and aims to identify optimal dosing regimens that maximize efficacy and safety in alignment with FDA’s Project Optimus.
Dr. Andrew Brenner, Professor-Research at UT Health San Antonio’s Mays Cancer Center, said they expect to enroll all required patients in Cohort 1 by year-end, assuming REYOBIQ maintains its safety profile.
The dose optimization study follows Phase 1 results where REYOBIQ delivered high radiation doses to the cranial subarachnoid space. Five of seven patients achieving over 80% reduction in LM tumor cells in cerebrospinal fluid survived at least one year post-treatment.
Plus Therapeutics plans to present additional data from the completed single-dose trial at the upcoming SNO/ASCO CNS Metastases Conference in August and will request an End of Phase 1 meeting with the FDA to discuss potential registrational trial design.
The trial is supported by a $17.6 million grant from the Cancer Prevention & Research Institute of Texas.
Leptomeningeal metastases affect approximately 5% of patients with metastatic cancer, particularly those with breast cancer, lung cancer, and melanoma. Current treatment options are limited, with median survival typically ranging from 2-6 months.
REYOBIQ is also being evaluated for recurrent glioblastoma and pediatric brain cancer in separate clinical trials.
The information in this article is based on a company press release statement.
In other recent news, Plus Therapeutics announced plans to begin the commercial rollout of its CNSide cerebrospinal fluid diagnostic platform in the second half of 2025. The platform, which aims to diagnose and monitor central nervous system cancer metastases, is projected to generate approximately $2 million in revenue in 2025, with expectations of growth to $38 million by 2032. Additionally, the U.S. Food and Drug Administration cleared Plus Therapeutics’ Investigational New Drug application for REYOBIQ, intended to treat pediatric patients with high-grade glioma and ependymoma. This trial will be funded by a $3.0 million grant from the U.S. Department of Defense. In financial restructuring news, Plus Therapeutics has restructured a $15 million equity financing to reduce potential dilution, canceling warrants that could have resulted in the issuance of approximately 1.51 billion shares. On the analyst front, H.C. Wainwright lowered its price target on Plus Therapeutics to $3.00, while Ascendiant Capital raised its price target to $20.50, both maintaining a Buy rating. Ascendiant Capital’s decision reflects confidence in the company’s drug development progress and future milestones expected in 2025. Plus Therapeutics reported $10 million in cash and no debt in the first quarter, with additional funds raised to sustain operations into 2026.
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