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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 (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.
Plus Therapeutics (PSTV) has reported its Q4 and full year 2024 financial results, highlighting significant developments in its CNS cancer therapeutics programs. The company secured a $15 million private placement financing, regaining Nasdaq compliance and extending runway into 2026, along with a $2 million grant advance from CPRIT.
Key highlights include FDA brand name approval for REYOBIQ, promising Phase 1 clinical trial results showing doubled median survival rates for glioblastoma patients, and FDA Orphan Drug Designation for leptomeningeal metastases treatment. The company strengthened its management team and expanded its agreement with Telix IsoTherapeutics for Rhenium-186 supply.
Financial results show $3.6 million in cash and investments as of December 31, 2024, $5.8 million in grant revenue, and a net loss of $13.0 million ($1.95 per basic share) for 2024.
Plus Therapeutics (Nasdaq: PSTV) announces FDA's conditional acceptance of REYOBIQ™ as the proprietary name for its lead therapeutic candidate. REYOBIQ™ (rhenium Re186 obisbemeda) is currently under clinical investigation for treating Leptomeningeal Metastases (LM) and Recurrent Glioblastoma (GBM), both central nervous system (CNS) cancers.
The company must submit a request for proprietary name review when filing the marketing application (NDA). This branding initiative aims to help investigators, investors, and potential patients better connect with the rhenium-based radiotherapeutic beyond its chemical composition.
Plus Therapeutics (PSTV), a clinical-stage pharmaceutical company focused on developing targeted radiotherapeutics for central nervous system (CNS) cancers, has scheduled its fourth quarter and full year 2024 financial results announcement for Thursday, March 27, 2025 after market close.
The company's management team will host a conference call and webcast at 5:00 p.m. ET to discuss financial results and provide a corporate update. Participants can pre-register through a dial-in link and are advised to join 15 minutes before the start time. A replay will be available on the company's website, with the webcast remaining accessible for 90 days following the live call.
Plus Therapeutics (PSTV), a clinical-stage pharmaceutical company focused on developing targeted radiotherapeutics for central nervous system cancers, has successfully regained compliance with Nasdaq's minimum stockholders' equity requirement as of March 7, 2025. The company's common stock will maintain its listing and continue trading on The Nasdaq Capital Market.
Plus Therapeutics (PSTV) has published promising Phase 1 clinical trial results for Rhenium (186Re) Obisbemeda in treating glioblastoma (GBM) in Nature Communications. The study demonstrated significant survival benefits:
Key findings from the trial of 21 patients include:
- Median overall survival of 11 months, exceeding the standard care's 8-month survival rate
- Patients receiving >100 Gy achieved 17-month median survival, compared to 6 months for those receiving 100 GyTreatment doses up to 22.3 mCi showed no dose-limiting toxicity
- Achieved tumor radiation doses up to 739.5 Gy without significant toxicity
The company is currently enrolling patients in its ReSPECT-GBM Phase 2 trial at leading medical centers.
Plus Therapeutics (PSTV) has received Orphan Drug Designation (ODD) from the FDA for Rhenium (186Re) Obisbemeda, targeting leptomeningeal metastases (LM) in lung cancer patients. This designation provides significant benefits including:
- 7 years potential market exclusivity
- Tax credits for qualified clinical trials
- Exemption from regulatory fees including $4.3M PDUFA charge in 2025
- PREA requirements exemption
The company has completed the ReSPECT-LM Phase 1 single-dose trial, establishing the recommended Phase 2 dose. Plus Therapeutics is now proceeding with a Phase 2 single-dose expansion trial and a Phase 1 multiple-dose trial, while working with the FDA to determine the optimal pivotal trial strategy.
Plus Therapeutics (PSTV), a clinical-stage pharmaceutical company focused on targeted radiotherapeutics for CNS cancers, has granted stock options to its new Chief Development Officer, Dr. Michael Rosol.
The equity award consists of options to purchase 30,000 shares of company common stock, with a four-year vesting schedule. One-fourth of the options will vest on the first anniversary, followed by equal monthly installments thereafter. The exercise price is set at the closing price of PSTV's common stock on February 28, 2025.
The options, granted outside the Company's 2020 Incentive Plan but with similar terms, are subject to Dr. Rosol's continued employment. The company has filed a Form S-8 for these equity awards, aiming to align the executive's interests with shareholders.