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Plus Therapeutics reports news on its CNS oncology business, which combines precision diagnostics with targeted radiopharmaceutical development for central nervous system cancers. Recurring updates cover REYOBIQ™ (rhenium Re186 obisbemeda), a radiotherapeutic program for indications including leptomeningeal metastases and recurrent glioblastoma, as well as clinical and translational presentations, regulatory designations, manufacturing technology transfer and supply-chain partnerships.
The company’s news also covers the commercial expansion of CNSide®, including payer coverage, Medicare enrollment and reimbursement work for its cerebrospinal fluid assay platform. Corporate updates include leadership appointments, equity inducement grants under Nasdaq rules, financial results, capital actions and listing-compliance matters tied to its Nasdaq-traded common stock.
Plus Therapeutics (NASDAQ:PSTV) announced a business update for its CNSide Diagnostics subsidiary, which is preparing for the U.S. commercial launch of its novel CNS cancer diagnostic platform in H2 2025. The CNSide CSF Assay Platform, acquired in 2024, addresses an estimated $6 billion U.S. market opportunity for central nervous system cancer metastases diagnosis.
The platform has demonstrated 92% sensitivity and 95% specificity, with over 11,000 tests performed at 200+ U.S. cancer institutions since 2020. The company has established a testing laboratory in Houston, TX, and plans to launch first in Texas before expanding to other states. While the launch is on track for 2025, meaningful revenue contributions are expected in fiscal year 2026.
Plus Therapeutics (NASDAQ:PSTV), a clinical-stage pharmaceutical company focused on developing targeted radiotherapeutics for central nervous system (CNS) cancers, will host a business update conference call on Thursday, June 26, 2025, at 9:00 AM ET.
The company will release its business update before market open, followed by a conference call and webcast where management will provide additional details. Participants are encouraged to pre-register through the provided dial-in link, and should join 15 minutes before the start time. A replay will be available on the company's website for 90 days following the live call.
Plus Therapeutics (NASDAQ:PSTV) has received FDA clearance for its Investigational New Drug (IND) application for REYOBIQ™, targeting pediatric brain cancers. The Phase 1/2a clinical trial, supported by a $3.0 million Department of Defense grant, will focus on treating children with high-grade glioma (HGG) and ependymoma.
The trial consists of two parts: a Phase 1a/b dose escalation study enrolling approximately 24 patients to determine maximum tolerated dose, and a Phase 2a efficacy study with 32 patients. REYOBIQ delivers targeted beta radiation directly to brain tumors while minimizing damage to healthy tissue. The therapy builds on promising results from the adult recurrent glioblastoma trial, which showed doubled overall survival in patients receiving therapeutic radiation doses.
Plus Therapeutics (Nasdaq: PSTV), a clinical-stage pharmaceutical company focused on CNS cancer treatments, has announced a major restructuring of its $15 million March 2025 equity financing. The restructuring eliminates potential dilution of up to 1.5 billion shares of common stock.
Key restructuring elements include: cancellation of warrants that could have issued 1.51 billion shares, leaving ~36 million shares issuable through amended Series B Warrants at 1:1 ratio; cancellation of ~25 million common shares or pre-funded warrants; and a provision requiring 90% of future capital raised after July 1, 2025, to repay holders at 115% of the original $0.66 per share price. The company has also filed to withdraw the related resale registration statement with the SEC.
Plus Therapeutics (PSTV) has received a delinquency notification from Nasdaq on May 21, 2025, due to delayed filing of its Q1 2025 Quarterly Report (Form 10-Q). The company is not in compliance with Nasdaq Listing Rule 5250(c)(1), which requires timely filing of periodic financial reports with the SEC.
While this notification has no immediate impact on PSTV's Nasdaq listing, the company must submit a compliance plan by July 21, 2025. If accepted, Nasdaq may grant an extension until November 17, 2025. Plus Therapeutics states it is working to file the report promptly and expects to resume normal filing schedules for the remainder of 2025.
Plus Therapeutics (NASDAQ: PSTV) presented new data for REYOBIQ™ (rhenium Re186 obisbemeda) from its Phase 1 ReSPECT-LM trial for Leptomeningeal Metastases (LM) at the 2025 Nuclear Medicine and Neurooncology Conference. Key findings include:
The trial demonstrated significant clinical benefits with a 76% Clinical Benefit Rate (13/17 patients showing partial response or stable disease) and 87% clinical response rate based on physician evaluation. The treatment showed dose-dependent effectiveness, reaching 253Gy in Cohort 5.
Notably, 5 out of 7 patients who showed >80% reduction in LM tumor cells survived at least one year after initial treatment, with three receiving additional treatment under compassionate use. RNA sequencing revealed early tumor cell death and enhanced immune response, while maintaining a favorable safety profile with limited dose-limiting toxicities.
Plus Therapeutics (PSTV), a clinical-stage pharmaceutical company focused on developing targeted radiotherapeutics for central nervous system (CNS) cancers, has announced its participation in the D. Boral Capital Inaugural Global Conference. The event will take place on May 14, 2025, at The Plaza Hotel in New York City. CEO Marc H. Hedrick, M.D., will be available for one-on-one meetings from 9:00 AM to 3:00 PM ET. Interested parties can schedule meetings by contacting John Perez at jperez@dboralcapital.com.
Plus Therapeutics (PSTV) has appointed Kyle Guse, J.D., M.B.A. to its Board of Directors, where he will serve as chair of the Audit Committee and on the Compensation Committee. Guse brings 30 years of professional experience, including a decade as CFO, General Counsel and Secretary at Atossa Therapeutics, a NASDAQ-listed company focused on breast cancer treatments.
Currently serving as Chief Legal Officer at NYSE-listed DDC Enterprise , Guse's background includes roles as a partner in top international law firms and as a Certified Public Accountant with a Big 4 firm. He holds a J.D. from Santa Clara University Law School and an M.B.A. from California State University, Sacramento.
Plus Therapeutics is developing targeted radiotherapeutics for central nervous system cancers, with key products including REYOBIQ™ and CNSide.
Plus Therapeutics (PSTV) has released new data from its Phase 1 ReSPECT-LM dose escalation trial for REYOBIQ™ (rhenium Re186 obisbemeda) in treating Leptomeningeal Metastases. The data will be presented at the Nuclear Medicine and Neurooncology conference in Vienna.
Key findings include:
- Dose-dependent increase in absorbed dose to cranial and spinal subarachnoid space, reaching 253Gy in Cohort 5
- 31% of patients (5 out of 16) showed partial response in neuroimaging
- 75% Clinical Benefit Rate through day 112 based on neuroimaging
- 86% Clinical Benefit Rate based on physician evaluation
- No dose limiting toxicity in first four cohorts; grade 4 thrombocytopenia observed in Cohorts 5 and 6
RNA sequencing revealed early induction of apoptosis, followed by innate immune response and increased T cells with adaptive immune response by Day 28.