Core Insights - Plus Therapeutics, Inc. is expanding its team at CNSide Diagnostics, LLC to enhance its capabilities in the CNS cancer diagnostics market, which is valued at over $6 billion in the U.S. [2][7] - The company is making progress towards a national launch and expanding test coverage, with plans for additional agreements with payors beyond existing contracts with UnitedHealthcare and Humana [2][8] Team Expansion - Mr. Prem Gurnani has been appointed as Senior Director of Lab Operations and Systems Implementation, bringing over 16 years of experience in diagnostics and clinical operations [8] - Ms. Elaine Luckey joins as Director of Quality and Regulatory Affairs, with over 20 years of experience in quality and regulatory affairs in laboratory environments [8] Equity Grants - The company granted stock options to Mr. Gurnani and Ms. Luckey, allowing them to purchase up to 33,750 shares each, with an exercise price equal to the closing stock price on December 4, 2025 [4][6] - Each executive also received 11,250 restricted stock units (RSUs), which will vest over three years, with one-third vesting on January 1, 2027 [5][6] Company Overview - Plus Therapeutics is a clinical-stage pharmaceutical company focused on developing targeted radiotherapeutics for challenging CNS cancers, aiming to improve clinical outcomes [8][9] - The company is advancing a pipeline of product candidates, particularly in leptomeningeal metastases and recurrent glioblastoma, supported by strategic partnerships for development and manufacturing [9]

Core Insights - Plus Therapeutics, Inc. presented positive clinical data for REYOBIQ at the WFNOS/SNO Annual Meeting, indicating no dosage limiting toxicity in the ReSPECT-LM trial and promising safety and efficacy in the ReSPECT-GBM trial [1][2][12] - The company aims to improve survival rates for patients with central nervous system (CNS) cancers through its expanding clinical data set and the CNSide diagnostic portfolio [2][12] ReSPECT-LM Trial - The Phase 1 trial for Leptomeningeal Metastases (LM) showed that REYOBIQ was well-tolerated at a maximum dose of 66 mCi, with a recommended Phase 2 dose of 44.1 mCi [7] - Enrollment in Cohort 1 has begun, with three patients treated without dose limiting toxicity [7] ReSPECT-GBM Trial - The Phase 1/2 trial for recurrent Glioblastoma (GBM) has enrolled 24 out of a planned 34 patients, with a recommended Phase 2 dose of 22.3 mCi based on safety profiles [8] - Efficacy data indicated a median overall survival of 17 months for patients receiving ≥100 Gy, compared to 6 months for those receiving <100 Gy, surpassing historical outcomes for bevacizumab monotherapy [14] Safety Profile - Most treatment-related adverse events in both Phase 1 and 2 trials were Grade 1 or 2, with no treatment-related deaths reported [9] - Common adverse events included lymphopenia (7.9%), cognitive disorder (7.0%), and headache (7.0%) [9] Imaging and Efficacy - MRI combined with SPECT imaging biomarkers effectively evaluates overall survival response in recurrent GBM treatment, aiding in personalized patient planning [12][14] - REYOBIQ's efficacy is positively correlated with treatment coverage ratio and progression-free survival, while negatively correlated with tumor volume [14] About REYOBIQ - REYOBIQ (rhenium Re186 obisbemeda) is a novel injectable radiotherapy designed for targeted high-dose radiation in CNS tumors, with potential advantages over currently approved therapies [15] - The drug is being evaluated in multiple clinical trials, including ReSPECT-GBM, ReSPECT-LM, and ReSPECT-PBC, with funding support from various institutions [15]

Core Insights - Plus Therapeutics has completed a Type B meeting with the FDA to discuss clinical development plans for REYOBIQ targeting leptomeningeal metastases [1][2] - The company plans to provide an update on next steps early in 2026 and will implement amendments to the LM trial based on FDA recommendations [2] About Leptomeningeal Metastases (LM) - LM is a severe complication of advanced cancer, occurring in approximately 5% of metastatic cancer patients, with a median survival of 2-6 months [3] - Common sources of LM include breast cancer, lung cancer, and melanoma, highlighting the urgent need for novel therapies [3] About REYOBIQ™ - REYOBIQ is a novel injectable radiotherapy designed for targeted high-dose radiation in CNS tumors, potentially improving patient outcomes compared to existing therapies [4] - It is being evaluated in clinical trials for recurrent glioblastoma, leptomeningeal metastases, and pediatric brain cancer, with significant funding support from various institutions [4] About CNSide Diagnostic, LLC - CNSide Diagnostics, a subsidiary of Plus Therapeutics, develops proprietary tests to identify tumor cells in the CNS, aiding in the management of patients with leptomeningeal metastases [5] About Plus Therapeutics - Plus Therapeutics is a clinical-stage pharmaceutical company focused on developing targeted radiotherapeutics for CNS cancers, with a pipeline that includes programs for LM and recurrent glioblastoma [6] - The company has established a supply chain through strategic partnerships to support the development and potential commercialization of its products [6]

Core Points - Plus Therapeutics, Inc. has received an additional 180-day extension from Nasdaq to comply with the $1.00 minimum bid price requirement, now having until May 11, 2026, to meet this requirement [1][2] - The extension does not affect the current listing status of the company's common stock on the Nasdaq Capital Market under the symbol "PSTV" [2] - If the closing bid price reaches at least $1.00 per share for 10 consecutive business days during the extension period, Nasdaq will confirm compliance and close the matter [2] Company Overview - Plus Therapeutics is a clinical-stage pharmaceutical company based in Houston, Texas, focused on developing targeted radiotherapeutics for central nervous system cancers [4] - The company combines image-guided local beta radiation with targeted drug delivery approaches, advancing a pipeline of product candidates, particularly in leptomeningeal metastases and recurrent glioblastoma [4] - Plus Therapeutics has established a supply chain through strategic partnerships to support the development, manufacturing, and potential commercialization of its products [4] Subsidiary Information - CNSide Diagnostics, LLC, a wholly owned subsidiary of Plus Therapeutics, develops proprietary laboratory tests, including CNSide®, to identify tumor cells that have metastasized to the central nervous system [5] - The CNSide® CSF Assay Platform allows for quantitative analysis of cerebrospinal fluid, aiding in the management of patients with leptomeningeal metastases [5]

Core Insights - Plus Therapeutics, Inc. is advancing its commercial readiness and diagnostic capabilities through the launch of its subsidiary, CNSide Diagnostic LLC, focusing on a laboratory-developed test for cerebrospinal fluid tumor cell enumeration [1][2][3] Commercial Developments - The company has expanded its manufacturing footprint and made significant progress in commercial readiness, including the appointment of key leadership roles to drive the CNSide diagnostic business [2][3] - CNSide has signed a national policy agreement with UnitedHealthcare, providing coverage for over 51 million people in the U.S., marking a significant step in expanding payor coverage [3][4] Leadership Appointments - Russ Havranek has been promoted to Executive Vice President, Commercial and Corporate Strategy, while Daniel Ortega has been appointed Vice President, Development and Technical Operations, both expected to play crucial roles in the company's growth [2][3][4] - Havranek brings over 28 years of experience in developing and commercializing diagnostic and therapeutic products, while Ortega has nearly 20 years of experience in the pharmaceutical industry [4][7] Manufacturing and Operations - CNSide has secured a new state-of-the-art laboratory in Houston, which will support current and future commercial production needs and enhance collaboration opportunities [6][7] - The new facility is strategically located within the Texas Medical Center, the largest medical center globally, which will facilitate scientific advancement and clinical development [7][11] Product and Service Focus - CNSide Diagnostics develops proprietary laboratory-developed tests aimed at identifying tumor cells that have metastasized to the central nervous system, particularly for patients with carcinomas and melanomas [8] - The CNSide CSF Assay Platform allows for quantitative analysis of cerebrospinal fluid, improving patient management for those with leptomeningeal metastases [8][9]