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Plus Therapeutics, Inc. (symbol: PSTV) is a cutting-edge clinical-stage pharmaceutical company based in Austin, Texas. Founded in 1996 and initially known as Cytori Therapeutics, Inc., the company rebranded to Plus Therapeutics in July 2019 to better reflect its mission and evolving focus. Specializing in the discovery, development, and manufacture of innovative treatments for cancer and other debilitating diseases, Plus Therapeutics aims to bring new hope to patients through cutting-edge medical solutions.
The company's lead product candidate is DocePLUS, a protein-stabilized, pegylated liposomal formulation of docetaxel specifically designed for the treatment of small cell lung cancer. Additionally, Plus Therapeutics is developing DoxoPLUS, a generic pegylated liposomal encapsulated doxorubicin aimed at treating breast and ovarian cancer, multiple myeloma, and Kaposi's sarcoma.
In a significant partnership, Plus Therapeutics has entered into a license agreement with NanoTx, Corp. to develop and commercialize NanoTx's glioblastoma treatment. This collaboration aims to propel the company further into the forefront of cancer treatment research.
One of the company's groundbreaking developments is the novel injectable radiotherapy called Rhenium (186Re) obisbemeda. This treatment is specifically formulated to deliver targeted high-dose radiation in Central Nervous System (CNS) tumors, optimizing patient outcomes while minimizing off-target risks. The product's efficacy and safety are being evaluated for recurrent glioblastoma and leptomeningeal metastases in the ReSPECT-GBM and ReSPECT-LM clinical trials. These trials are supported by grants from the National Cancer Institute (NCI) and the Cancer Prevention & Research Institute of Texas (CPRIT), totaling millions in funding.
Financially, Plus Therapeutics recently secured $6.5 million in upfront gross proceeds, with the potential to receive up to an additional $11.5 million through potential warrant exercise, amounting to approximately $18 million in total gross proceeds. These funds will be essential in advancing the company’s robust pipeline and bringing innovative treatments to market.
Investors and stakeholders can stay informed of the latest developments and financial updates by reaching out to key contacts such as Corey Davis, Ph.D. of LifeSci Advisors, and Charles Y. Huang, MBA, Director of Capital Markets and Investor Relations.
Plus Therapeutics, Inc. (PSTV) has announced a significant update following a Type C meeting with the FDA regarding the cGMP production of its investigational radiotherapeutic, 186RNL, aimed at treating recurrent glioblastoma. The FDA supports the company’s CMC practices, aligning with its proposed manufacturing and release strategies. This endorsement is crucial as Plus Therapeutics prepares for ongoing and future ReSPECT™ clinical trials, with cGMP 186RNL expected to be available in the second half of 2022. The company emphasizes that this regulatory clarity mitigates risks of potential delays.
Plus Therapeutics, Inc. (PSTV) has announced an oral presentation at the European Society for Medical Oncology (ESMO) Congress 2022 regarding its Phase 1/2a ReSPECT-GBM™ clinical trial. The trial evaluates Rhenium-186 NanoLiposome (186RNL) for treating recurrent glioblastoma. The presentation is scheduled for September 9, 2022, at 14:00 CEST, led by Dr. Andrew J. Brenner. This investigation aims to demonstrate the safety and efficacy of 186RNL in delivering high doses of radiation directly to tumors through Convection Enhanced Delivery (CED).
Plus Therapeutics (PSTV) has secured a $17.6 million grant from the Cancer Prevention and Research Institute of Texas (CPRIT) to advance Rhenium-186 NanoLiposome (186RNL) aimed at treating leptomeningeal metastases. This funding will cover a significant portion of the developmental costs for the next three years. Additionally, the clinical trial for 186RNL continues to progress with Cohort 1 enrollment completed, demonstrating no dose-limiting toxicities. The therapy has received FDA Fast Track designation, indicating significant potential in addressing this severe cancer complication.
Plus Therapeutics, Inc. (PSTV) announced a share repurchase program authorized for up to $2.0 million of its outstanding common stock, signaling strong confidence in its long-term strategy and balance sheet. The program will be funded through available cash and executed based on market conditions over the next 12 months. The company intends to utilize Rule 10b5-1 trading plans for buybacks, while maintaining flexibility to adjust the program as needed. This initiative underlines Plus Therapeutics' commitment to enhancing shareholder value.
Plus Therapeutics (PSTV) showcased positive findings from ongoing trials of Rhenium-186 Nanoliposome (186RNL) for treating recurrent glioblastoma (GBM) and leptomeningeal metastases at the 2022 CNS Clinical Trials Conference. The Phase 1/2a trial reported safe administration of 186RNL, demonstrating a substantial decrease in cerebrospinal fluid (CSF) cell count in treated patients. Additionally, significant overall survival benefits were noted in GBM patients receiving high radiation doses. The company aims to continue clinical evaluations and further dose escalations.
Plus Therapeutics (PSTV) announced the presentation of data from two clinical trials targeting recurrent glioblastoma and leptomeningeal metastases at the 2022 CNS Clinical Trials and Brain Metastases Conference on August 12-13, 2022. The oral presentation will focus on the safety and feasibility of Rhenium-186 Nanoliposome in leptomeningeal metastases, while a poster will cover its use in recurrent glioma as part of the ReSPECT Phase 1 Trial. This showcases advancements in innovative, targeted radiotherapeutics for challenging cancer types.
Plus Therapeutics (PSTV) announced that Dr. Norman LaFrance will present on their investigational targeted radiotherapeutic, Rhenium-186 NanoLiposome (186RNL), at the Targeted Radiopharmaceuticals Summit in Boston on July 27, 2022. The presentation is titled ‘Radiolabeled NanoLiposomes: A Novel Targeted Treatment for Rare and Central Nervous System Cancers’, and will provide updates on the U.S. ReSPECT clinical trials. Plus Therapeutics focuses on developing innovative cancer therapies, utilizing advanced nanotechnology for drug delivery.
Plus Therapeutics (PSTV) announced the completion of Cohort 1 enrollment in the ReSPECT-LM Phase 1/2a trial for 186RNL, targeting leptomeningeal metastases. The company achieved key manufacturing objectives and presented positive interim data on 186RNL for glioblastoma. Financially, cash stood at $18.1 million with a net loss of $5.3 million for Q2 2022. Operating expenses rose to $5.1 million due to CMC development costs. The company plans multiple data presentations and aims to finalize GMP production for ongoing clinical trials by the end of 2022.
Plus Therapeutics, Inc. (PSTV) announced it will report its second quarter 2022 financial results on July 21, 2022, post-market. Following this, management will host a conference call at 5:00 p.m. ET to discuss results and provide corporate updates. A live webcast will be available, and participants can pre-register for the call. Plus Therapeutics focuses on innovative, targeted radiotherapeutics for tough cancers, employing proprietary nanotechnology for enhanced drug delivery.
Plus Therapeutics (PSTV) has successfully completed technology transfer and initiated cGMP manufacturing of its Rhenium-186 NanoLiposome (186RNL) drug intermediate with Piramal Pharma Solutions. This milestone supports ongoing clinical trials for rare cancers. The 186RNL product is currently undergoing stability testing and adheres to FDA guidelines. The company is on track to provide GMP drug availability in late 2022 for trials focusing on recurrent glioblastoma and leptomeningeal metastases. Feedback from recent FDA meetings will guide future clinical development plans.
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