Retreatment Rhenium Liposome

Multiple long-term LM survivors in those patients receiving multiple doses of REYOBIQ RNA sequencing data show early tumor apoptosis and activation of innate immune responses Updated ReSPECT data presented at the 2025 Nuclear Medicine and Neurooncology Conference May 14, 2025 -- Plus Therapeutics, Inc. (Nasdaq: PSTV) (the “Company”), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system (CNS) cancers, announces the presentation of new data on its lead drug REYOBIQ™ (rhenium Re186 obisbemeda) during both an oral presentation and a poster presented at the Nuclear Medicine and Neurooncology Conference. The meeting was held May 9-10, 2025 in Vienna, Austria. "This newly presented data shows safety, clinical benefit and data supporting the underlying mechanism of action for REYOBIQ in patients with Leptomeningeal Metastases," said Marc H. Hedrick, M.D., Plus Therapeutics President and Chief Executive Officer. "Furthermore, multiple doses of REYOBIQ were administered under compassionate use, mirroring how REYOBIQ may one day be used post approval and can contribute to long term survival in LM.” The study, titled, “Rhenium Obisbemeda (REYOBIQ) in Leptomeningeal Metastases,” highlights additional data from the Company’s now complete Phase 1 ReSPECT-LM dose escalation trial. The presented data added further detail to the previously reported data from the submitted abstract, which demonstrated: Dose dependent increase in the average absorbed dose to the cranial and spinal subarachnoid space reaching 253Gy in Cohort 5 Neuroimaging response data was available for 17 patients as of the data cutoff with five of those (29%) showing a partial response An additional eight patients showed stable disease by neuroimaging through day 112 for a Clinical Benefit Rate (complete response + partial response + stable disease) of 76% (13/17 – five partial responses and eight stable disease). Additionally, 87% of subjects demonstrated clinical response based on the physician evaluation (13/15 – 2 response and 11 stable disease) No dose limiting toxicity (DLT) observed in the first four cohorts, with a grade 4 DLT (thrombocytopenia), one in each of Cohorts 5 and 6 RNA sequencing of LM cells showed early induction of apoptosis, with an innate immune response followed by an increase in T cells and an adaptive immune response by Day 28. In addition, of the seven patients who received a response of better than 80% in reduction of LM tumor cells in the cerebrospinal fluid, five survived at least one year following initial treatment. The study reports that three of those five were retreated via compassionate use. LM is a rare complication of cancer in which the primary cancer spreads to the cerebrospinal fluid (CSF) and leptomeninges surrounding the brain and spinal cord. All malignancies originating from solid tumors, primary brain tumors, or hematological malignancies have this LM complication potential with breast cancer as the most common cancer linked to LM, with 3-5% of breast cancer patients developing LM. Additionally, lung cancer, GI cancers and melanoma can also spread to the CSF and result in LM. LM occurs in approximately 5% of people with cancer and is usually terminal with 1-year and 2-year survival of just 7% and 3%, respectively. The incidence of LM is on the rise, partly because cancer patients are living longer and partly because many standard chemotherapies cannot reach sufficient concentrations in the spinal fluid to kill the tumor cells, yet there are no FDA-approved therapies specifically for LM patients, who often succumb to this complication within weeks to several months, if untreated. REYOBIQ™ (rhenium Re186 obisbemeda) is a novel injectable radiotherapy specifically formulated to deliver direct targeted high dose radiation in CNS tumors in a safe, effective, and convenient manner to optimize patient outcomes. REYOBIQ™ has the potential to reduce off target risks and improve outcomes for CNS cancer patients, versus currently approved therapies, with a more targeted and potent radiation dose. Rhenium-186 is an ideal radioisotope for CNS therapeutic applications due to its short half-life, beta energy for destroying cancerous tissue, and gamma energy for real-time imaging. REYOBIQ™ is being evaluated for the treatment of recurrent glioblastoma and leptomeningeal metastases in the ReSPECT-GBM and ReSPECT-LM clinical trials. ReSPECT-GBM is supported by an award from the National Cancer Institute (NCI), part of the U.S. National Institutes of Health (NIH), and ReSPECT-LM is funded by a three-year $17.6M grant by the Cancer Prevention & Research Institute of Texas (CPRIT). Headquartered in Houston, Texas, Plus Therapeutics, Inc. is a clinical-stage pharmaceutical company developing targeted radiotherapeutics for difficult-to-treat cancers of the central nervous system with the potential to enhance clinical outcomes. Combining image-guided local beta radiation and targeted drug delivery approaches, the Company is advancing a pipeline of product candidates with lead programs in leptomeningeal metastases (LM) and recurrent glioblastoma (GBM). The Company has built a supply chain through strategic partnerships that enable the development, manufacturing, and future potential commercialization of its products. The content above comes from the network. if any infringement, please contact us to modify.

HOUSTON, April 23, 2025 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV) (the “Company”), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system (CNS) cancers, announces the appointment of Kyle Guse, J.D., M.B.A. to the Company’s Board of Directors where he will serve as chair of the Audit Committee and on the Compensation Committee. “Kyle’s decades of financial, transactional and operational experience in our industry will make an immediate and positive impact to Plus’ board of directors,” said Marc H. Hedrick, M.D., Plus Therapeutics President and Chief Executive Officer. “Furthermore, in his role as audit chair, Kyle will be a force in the successful execution of Plus’ ambitious business plan and driving stockholder value.” Mr. Guse is an executive with 30 years of professional experience leading the world’s most innovative companies. For over a decade he served as Chief Financial Officer, General Counsel and Secretary of Atossa Therapeutics, Inc., a NASDAQ-listed company developing a drug to prevent and treat breast cancer, which had previously developed and marketed medical devices, and that owned and operated a CLIA certified laboratory. Currently, he serves as Chief Legal Officer of DDC Enterprise Ltd., an NYSE-listed international consumer foods company. Formerly, he was a partner and practiced corporate law at several of the top international law firms. Prior to that, he was a Certified Public Accountant with a Big 4 accounting firm. He earned his J.D. (cum laude) from Santa Clara University Law School and an M.B.A. from California State University, Sacramento, where he also earned his Bachelor of Science degree. “Plus Therapeutics has multiple and significant opportunities in both the therapeutics and diagnostics markets with REYOBIQ™ (rhenium Re186 obisbemeda) and CNSide, and I believe it has tremendous potential to make an impact on the market,” said Mr. Guse. “I’m looking forward to collaborating closely with the Board and with management to help bring the Company to its full potential for stockholders, practitioners, and patients.” About Plus TherapeuticsHeadquartered in Houston, Texas, Plus Therapeutics, Inc. is a clinical-stage pharmaceutical company developing targeted radiotherapeutics for difficult-to-treat cancers of the central nervous system with the potential to enhance clinical outcomes. Combining image-guided local beta radiation and targeted drug delivery approaches, the Company is advancing a pipeline of product candidates with lead programs in leptomeningeal metastases (LM) and recurrent glioblastoma (GBM). The Company has built a supply chain through strategic partnerships that enable the development, manufacturing, and future potential commercialization of its products. For more information, visit https://plustherapeutics.com/. Cautionary Statement Regarding Forward-Looking StatementsThis press release contains statements that may be deemed “forward-looking statements” within the meaning of U.S. securities laws, including statements regarding clinical trials, expected operations and upcoming developments. All statements in this press release other than statements of historical fact are forward-looking statements. These forward-looking statements may be identified by future verbs, as well as terms such as “expect” “potential,” “anticipating,” “planning” and similar expressions or the negatives thereof. Such statements are based upon certain assumptions and assessments made by management in light of their experience and their perception of historical trends, current conditions, expected future developments and other factors they believe to be appropriate. These statements include, without limitation, statements regarding the potential promise of REYOBIQ™, expectations as to the Company’s future performance, including the next steps in developing the Company’s product candidates; the Company’s clinical trials, including statements regarding the timing and characteristics of the ReSPECT-LM single dose and multi-dose clinical trials; the continued evaluation of rhenium (186Re) obisbemeda including through evaluations in additional patient cohorts. The forward-looking statements included in this press release could differ materially from those expressed or implied by these forward-looking statements because of risks, uncertainties, and other factors that include, but are not limited to, the following: the early stage of the Company’s product candidates and therapies; the results of the Company’s research and development activities, including uncertainties relating to the clinical trials of its product candidates and therapies; the Company’s liquidity and capital resources and its ability to raise additional cash; the outcome of the Company’s partnering/licensing efforts, risks associated with laws or regulatory requirements applicable to it; market conditions, product performance, litigation or potential litigation, and competition within the cancer diagnostics and therapeutics field; ability to develop and protect proprietary intellectual property or obtain licenses to intellectual property developed by others on commercially reasonable and competitive terms; challenges associated with radiotherapeutic manufacturing, production and distribution capabilities necessary to support the Company’s clinical trials and any commercial level product demand; and material security breach or cybersecurity attack affecting the Company’s operations or property. This list of risks, uncertainties, and other factors is not complete. Plus Therapeutics discusses some of these matters more fully, as well as certain risk factors that could affect Plus Therapeutics’ business, financial condition, results of operations, and prospects, in its reports filed with the SEC, including Plus Therapeutics’ annual report on Form 10-K for the fiscal year ended December 31, 2024, quarterly reports on Form 10-Q, and current reports on Form 8-K. These filings are available for review through the SEC’s website at www.sec.gov. Any or all forward-looking statements Plus Therapeutics makes may turn out to be wrong and can be affected by inaccurate assumptions Plus Therapeutics might make or by known or unknown risks, uncertainties, and other factors, including those identified in this press release. Accordingly, you should not place undue reliance on the forward-looking statements made in this press release, which speak only as of its date. The Company assumes no responsibility to update or revise any forward-looking statements to reflect events, trends or circumstances after the date they are made unless the Company has an obligation under U.S. federal securities laws to do so. Investor ContactCORE IRinvestor@plustherapeutics.com