Plus Therapeutics Inc Stock Price, News & Analysis

Plus Therapeutics (NASDAQ:PSTV) has announced the successful treatment of initial patients in its ReSPECT-LM dose optimization trial for REYOBIQ™ (rhenium Re186 obisbemeda) targeting leptomeningeal metastases (LM). The trial follows promising Phase 1 results where 5 out of 7 patients achieved over 80% reduction in LM tumor cells and survived at least one year post-treatment.

The dose optimization study, supported by a $17.6 million CPRIT grant, aims to determine optimal dosing for efficacy and safety in alignment with FDA's Project Optimus. The company expects to complete Cohort 1 enrollment by year-end and plans to present additional Phase 1 data at the SNO/ASCO CNS Metastases Conference in August 2025.

Plus Therapeutics (NASDAQ:PSTV) has announced FDA agreement to initiate the ReSPECT-LM dose optimization trial for REYOBIQ™ (rhenium Re186 obisbemeda) in treating leptomeningeal metastases (LM). The trial, supported by a $17.6 million grant from the Cancer Prevention & Research Institute of Texas, builds upon promising results from their completed Phase 1 trial.

The dose optimization study will enroll up to 24 patients across four cohorts, evaluating multiple-dose regimens of REYOBIQ at the recommended Phase 2 dose of 44.1 mCi. The trial will be conducted at two Texas cancer centers: the University of Texas Health Science Center at San Antonio and the University of Texas Southwestern Medical Center.

The completed Phase 1 trial demonstrated encouraging results, including a 76% clinical benefit rate in neuroimaging results, with 29% achieving partial responses and 47% maintaining stable disease. Notably, 5 of 7 patients with over 80% reduction of LM tumor cells in CSF survived at least one year after initial treatment.

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) reported Q1 2025 financial results and business updates, highlighting progress in their REYOBIQ radiotherapeutic trials and CNSide CSF assay platform. The company raised $15M through private placement and received a $2M CPRIT grant advance. Key developments include positive Phase 1 REYOBIQ trial results showing doubled median survival in GBM patients, FDA Orphan Drug Designation for LM treatment, and strategic management additions. Financial results showed a cash balance of $9.9M (vs $0.1M in Q4 2024), grant revenue of $1.1M (vs $1.7M in Q1 2024), and a net loss of $17.4M or $(1.19) per share (vs $3.3M or $(0.75) per share in Q1 2024).

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.