PLUS THERAPEUTICS, Inc. - PSTV STOCK NEWS

Plus Therapeutics (PSTV) has successfully treated the first patient in Cohort 8 of its ReSPECT-GBM Phase 1/2a trial for rhenium (186Re) obisbemeda in recurrent glioblastoma. The trial has treated 25 patients without dose-limiting toxicities. Cohort 8 is now enrolling with a dose of 41.5 mCi, allowing treatment of larger tumors. The Phase 2 trial has treated five patients with a lower dose of 22.3 mCi. So far, safety and efficacy signals from the trials are promising, with no treatment-emergent toxicities noted. The FDA has granted Orphan Drug and Fast Track designations for this investigational therapy.

Plus Therapeutics (PSTV) has successfully initiated treatment of the first patient in Cohort 3 of its ReSPECT-LM Phase 1/2a clinical trial, aimed at treating leptomeningeal metastases from solid tumors. This follows the completion of previous cohorts without observing dose-limiting toxicities, with doses administered up to 26.4 millicuries. Encouraging safety and response data have been reported, showing significant reductions in cerebrospinal fluid tumor cell counts. The FDA has granted Fast Track designation for the therapy, supported by a $17.6 million grant from CPRIT. Preliminary results are expected to be presented in the latter half of 2023.

Plus Therapeutics announced the initiation of Phase 2 and Phase 1 trials for CNS cancers, focusing on rhenium (186Re) obisbemeda. The company secured a $17.6 million grant from the Cancer Prevention & Research Institute of Texas to support clinical development for leptomeningeal metastases. Their cash balance stood at $18.1 million as of December 31, 2022, sufficient to fund operations through 2025. The net loss for 2022 was $20.3 million, or $(0.77) per share. A conference call is scheduled for today to discuss financial results and future objectives, including expanding clinical trials and presenting safety data by the end of 2023.

Plus Therapeutics, Inc. (PSTV) has announced it will report its fourth quarter and full year 2022 financial results on February 23, 2023, after market close. Following the release, the management team will host a conference call and webcast at 5:00 p.m. ET to discuss the results and provide corporate updates. The company specializes in developing innovative radiotherapeutics for difficult-to-treat cancers, utilizing proprietary nanotechnology for improved drug delivery. A live webcast will be available and the replay can be accessed on their website for 90 days post-call.

Plus Therapeutics (PSTV) announced the completion of enrollment for Cohort 2 in the ReSPECT-LM Phase 1/2a clinical trial studying rhenium-186 obisbemeda for treating leptomeningeal metastases (LM). Anticipated data from Phase 1/Part A is expected in the second half of 2023. Initial results indicated that patients experienced a 46% to 92% reduction in cerebrospinal fluid tumor cell count post-treatment. The FDA has granted Fast Track designation for the therapy, supported by a $17.6 million grant from CPRIT. Next steps include a DSMB review and potential dose expansion discussions with the FDA.

Plus Therapeutics (PSTV) announced that the first patient has been dosed in the ReSPECT-GBM Phase 2b trial, evaluating rhenium (186Re) obisbemeda for recurrent glioblastoma (GBM). This multi-center trial aims to assess the safety and efficacy of direct tumor infusion using convection-enhanced delivery. Preliminary results from an earlier Phase 1/2a trial suggested a significant correlation between absorbed radiation dose and overall survival rates. The Phase 2b trial anticipates enrolling 31 patients over two years, supported by funding from the National Cancer Institute. The FDA has granted Orphan Drug and Fast Track designations for this innovative treatment.

Plus Therapeutics (PSTV) announced positive updates on its ReSPECT-GBM clinical trial of rhenium-186 obisbemeda for recurrent glioblastoma, showing safety and promising overall survival correlations with radiation doses. The Phase 2 trial enrollment has started, following a successful initial phase with no significant toxicities. Findings indicated a 35.7% reduction in death risk per 100 Gy dose increase. Additionally, the company is advancing into pediatric cancer trials, alongside updates on the ReSPECT-LM trial demonstrating good safety and efficacy in treating leptomeningeal metastases.

Plus Therapeutics (PSTV) announced plans to present data from ongoing clinical trials involving its investigational targeted radiotherapeutic, rhenium-186 obisbemeda, at the Society for Neuro-Oncology's 27th Annual Meeting between November 16-20, 2022. Data on recurrent glioblastoma and leptomeningeal metastases will be shared through oral presentations, with further insights into pediatric brain cancer planned for a poster session. Notable presentations will occur on November 19, including initial clinical experiences from the ReSPECT trials, which aim to provide innovative treatments for difficult-to-treat cancers.

Plus Therapeutics (PSTV) announced that the WHO has assigned the non-proprietary name Rhenium (186Re) obisbemeda to its lead investigational targeted radiotherapeutic, formerly known as 186RNL. This milestone aligns with the company's plans to advance towards mid- and late-stage clinical development, including a Phase 2 trial for recurrent glioblastoma by the end of 2022. The company focuses on innovative treatments for cancer, utilizing advanced liposomal encapsulation technology.