HOUSTON, March 10, 2025 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (NASDAQ:PSTV) (the "Company" or "Plus Therapeutics"), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system cancers, today announced that on March 7, 2025 the Company received confirmation from Nasdaq that the Company has regained compliance with Nasdaq's minimum stockholders' equity requirement. The Company's common stock will continue to be listed and t ...

Shares of Plus Therapeutics, Inc. (PSTV) were up a whopping 311.4% on March 6 after the company announced that the FDA has granted an Orphan Drug Designation (“ODD”) to its lead radiotherapeutic candidate, rhenium (186Re) obisbemeda, for treating leptomeningeal metastases (“LM”) in patients with lung cancer. The stock continued to gain another 51.4% in after-hours trading following the news announcement.The FDA grants ODD to support the development of medicines for rare disorders that affect fewer than 200, ...

Rhenium (186Re) Obisbemeda demonstrates safety, response, and potential efficacy for glioblastoma (GBM) patients Patients receiving >100 Gy of Rhenium (186Re) Obisbemeda achieved a median overall survival of 17 months, more than double the 8-month median overall survival with standard of care HOUSTON, March 07, 2025 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV) (“Plus” or the “Company”), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform techno ...

Core Viewpoint - Plus Therapeutics has received Orphan Drug Designation from the FDA for Rhenium (186Re) Obisbemeda, aimed at treating leptomeningeal metastases in lung cancer patients, highlighting the urgent need for new therapies in this underserved area [1][2]. Company Overview - Plus Therapeutics, Inc. is a clinical-stage pharmaceutical company focused on developing targeted radiotherapeutics for central nervous system cancers, with a pipeline that includes treatments for recurrent glioblastoma and leptomeningeal metastases [6][7]. - The company utilizes advanced platform technologies that combine image-guided local beta radiation and targeted drug delivery approaches to enhance clinical outcomes for patients [6]. Product Development - Rhenium (186Re) Obisbemeda is a novel injectable radiotherapy designed to deliver targeted high-dose radiation to CNS tumors, potentially improving patient outcomes compared to existing therapies [5]. - The company has completed the ReSPECT-LM Phase 1 single-dose trial, establishing the recommended Phase 2 dose, and is advancing into further clinical trials [3]. Market Context - Leptomeningeal metastases (LM) is a rare but serious complication of cancer, affecting approximately 5% of cancer patients, with a particularly high incidence in lung cancer and breast cancer [4]. - There are currently no FDA-approved therapies specifically for LM patients, emphasizing the critical need for innovative treatments in this area [4]. Regulatory Milestones - The Orphan Drug Designation provides several benefits, including seven years of market exclusivity, tax credits for clinical trials, and exemptions from significant regulatory fees, which can facilitate the development and commercialization of Rhenium (186Re) Obisbemeda [2].

HOUSTON, March 04, 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, today announced the pricing of a private placement with gross proceeds to the Company expected to be approximately $15.0 million. “This financing coupled with ongoing grant support strengthens our ability to rapidly advance our CNS cancer therapies,” said ...

AUSTIN, Texas, Feb. 26, 2025 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (NASDAQ:PSTV) (the "Company" or "Plus Therapeutics"), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system (CNS) cancers, today announced the completion of the ReSPECT-LM Phase 1 single-dose escalation trial, having determined an RP2D. The ReSPECT-LM single-dose escalation trial assessed the safety, tolerability, and potential efficacy of intratheca ...

Core Insights - Plus Therapeutics, Inc. has appointed Russell Bradley as President and General Manager of its subsidiary CNSide Diagnostics, LLC, aiming to enhance its operations in the diagnostic landscape for CNS cancers [2][3] - The company has also appointed Dr. Marc Hedrick, Mr. Rick Hawkins, and Mr. Russell Bradley to the CNSide Board of Directors, while Dr. Jonathan Stein has been named Medical Director [2][3] Company Developments - Russell Bradley brings over 30 years of leadership experience in diagnostics and life sciences, having held senior roles at Abbott Laboratories, Luminex Corporation, and Beckman Coulter, and is expected to make an immediate impact on CNSide [3] - The immediate priority for CNSide Diagnostics is to support early access and initial launch plans in the U.S. for its diagnostic tools targeting leptomeningeal disease [4] Product and Market Focus - CNSide Diagnostics develops proprietary laboratory-developed tests designed to identify tumor cells that have metastasized to the central nervous system, particularly for patients with carcinomas and melanomas [6] - The CNSide platform includes four laboratory-developed tests for treatment selection and monitoring of patients with leptomeningeal metastases, utilizing both cellular and molecular assays [7][8] - The CNSide CSF tumor cell enumeration LDT is currently being used in the ReSPECT-LM trial and is expected to be commercially available in 2025 [8] Industry Context - Leptomeningeal metastases (LM) is a rare but serious complication of cancer, affecting approximately 5% of cancer patients, with a particularly high incidence in breast cancer patients [5] - There are currently no FDA-approved therapies specifically for LM patients, highlighting a significant unmet medical need in the market [5]

Core Insights - Plus Therapeutics, Inc. has appointed Russell Bradley as President and General Manager of its subsidiary CNSide Diagnostics, LLC, aiming to enhance its operations in the diagnostic landscape for CNS cancers [2][3] - The company has also appointed Dr. Marc Hedrick, Mr. Rick Hawkins, and Mr. Russell Bradley to the CNSide Board of Directors, with Dr. Jonathan Stein as the new Medical Director [2][3] Company Developments - Russell Bradley brings over 30 years of experience in diagnostics and life sciences, having held senior roles at Abbott Laboratories, Luminex Corporation, and Beckman Coulter, and is expected to make an immediate impact on CNSide [3] - The immediate priority for CNSide Diagnostics is to support early access and initial launch plans in the U.S. for its diagnostic tools targeting leptomeningeal disease [4] Product and Market Focus - CNSide Diagnostics is focused on developing proprietary laboratory-developed tests to identify tumor cells that have metastasized to the central nervous system, particularly for patients with carcinomas and melanomas [6] - The CNSide platform includes four laboratory-developed tests for treatment selection and monitoring of patients with leptomeningeal metastases, utilizing both cellular and molecular assays [7][8] Industry Context - Leptomeningeal metastases (LM) is a rare but serious complication of cancer, affecting approximately 5% of cancer patients, with a particularly high incidence in breast cancer patients [5] - There are currently no FDA-approved therapies specifically for LM patients, highlighting a significant unmet medical need in this area [5]

Core Insights - Plus Therapeutics, Inc. has appointed Michael Rosol, Ph.D., as Chief Development Officer to lead clinical, pre-clinical, and biomarker development activities as the company transitions from mid-stage to pivotal trials in 2026 [1][2] - Dr. Rosol brings 25 years of experience in clinical trial design and operations, having previously served as Chief Medical Officer at Navidea Biopharmaceuticals and held key roles at Novartis Pharmaceuticals [2][3] - The company is focused on developing targeted radiotherapeutics for central nervous system cancers, specifically recurrent glioblastoma (GBM) and leptomeningeal metastases (LM), which currently lack FDA-approved therapies [5] Company Overview - Plus Therapeutics is a clinical-stage pharmaceutical company developing targeted radiotherapeutics aimed at enhancing clinical outcomes for patients with difficult-to-treat CNS cancers [5] - The company utilizes image-guided local beta radiation and targeted drug delivery approaches, with a pipeline that includes lead programs in recurrent GBM and LM [5] - Plus Therapeutics has established a supply chain through strategic partnerships to support the development, manufacturing, and potential commercialization of its products [5] Disease Context - Leptomeningeal metastases (LM) occur in approximately 5% of cancer patients and are often terminal, with a one-year survival rate of only 7% [3] - Glioblastoma (GBM) affects around 15,000 patients annually in the U.S., with an average life expectancy of less than 24 months and a one-year survival rate of 40% [4] - There are currently no FDA-approved treatments for recurrent GBM that significantly extend patient life, highlighting a critical need for effective therapies [4]

Core Points - Plus Therapeutics, Inc. has closed a private placement financing of approximately $3.7 million and received a $2.0 million advance from CPRIT to support clinical development of Rhenium (Re) Obisbemeda for leptomeningeal metastases and the CNSide LM diagnostic test [1][8][12] Private Placement Financing - The private placement involved the issuance of secured convertible promissory notes totaling $3,362,251 and common stock purchase warrants for up to 3,002,009 shares at an exercise price of $1.12 per share [3][4] - The notes have a one-year maturity and are convertible into common stock at the investors' discretion [3][4] - The gross proceeds from the private placement were approximately $3.7 million before deducting offering expenses [5] CPRIT Funding Advance - The $2.0 million advance from CPRIT is part of a larger $17.6 million grant award, with approximately $5.2 million remaining after this advance [8][9] - This funding will accelerate the clinical development of Rhenium (Re) Obisbemeda and the CNSide LM diagnostic test [8] Company Strategy and Future Plans - The capital raised is expected to fully support the completion of two planned LM trials, positioning the company for a pivotal trial in 2026 [2] - The CNSide diagnostic test is planned for commercialization in the U.S. in 2025 [16][17] About Rhenium (Re) Obisbemeda - Rhenium (Re) Obisbemeda is a novel injectable radiotherapy aimed at treating CNS tumors, specifically recurrent glioblastoma and leptomeningeal metastases [13][18] - The treatment utilizes Rhenium-186, which is suitable for CNS therapeutic applications due to its properties [13] About Leptomeningeal Metastases (LM) - LM is a rare but serious complication of cancer, occurring in approximately 5% of cancer patients, often leading to terminal outcomes [12] - There are currently no FDA-approved therapies specifically for LM patients, highlighting a significant unmet medical need [12]