Plus Therapeutics Inc. (NASDAQ:PSTV) stock is down during trading session on Wednesday following the company’s announcement of a public offering.The stock’s decline comes as the broader markets experienced a mixed session, with major indices like the S&P 500 and Nasdaq both closing lower on the previous trading day.The company priced its underwritten public offering at $0.38 per unit, consisting of one share of common stock and one warrant, aiming to raise approximately $15 million before expenses.PSTV stoc ...

Core Viewpoint - Plus Therapeutics, Inc. has announced a public offering of 39,473,684 units at a price of $0.38 per unit, aiming to raise approximately $15 million in gross proceeds for working capital and general corporate purposes [1][2]. Group 1: Offering Details - Each unit consists of one share of common stock and one warrant, with each warrant exercisable at $0.38 per share and expiring five years from issuance [1]. - The underwriter has a 30-day option to purchase up to an additional 5,921,052 shares and/or warrants to cover over-allotments [1]. Group 2: Financial and Regulatory Information - The offering is expected to close on January 15, 2026, subject to customary closing conditions [2]. - A registration statement related to the securities was filed with the SEC on January 9, 2026, and declared effective on January 13, 2026 [3]. Group 3: Company Overview - Plus Therapeutics is a clinical-stage pharmaceutical company focused on developing targeted radiotherapeutics for challenging CNS cancers, with a pipeline that includes programs for leptomeningeal metastases and recurrent glioblastoma [5]. - The company has established a supply chain through strategic partnerships to support the development and potential commercialization of its products [5]. Group 4: Subsidiary Information - CNSide Diagnostics, LLC, a wholly owned subsidiary of Plus Therapeutics, develops proprietary tests like CNSide® to identify tumor cells in the CNS for patients with carcinomas and melanomas [6].

Core Insights - Cellectar Biosciences plans to submit for conditional marketing approval for iopofosine I 131 in Europe by Q3 2026, following guidance from the EMA [1][5] - The company aims to present final results from the Phase 2 CLOVER WaM clinical study of iopofosine I 131 and initiate a Phase 1b study for CLR 125 targeting triple-negative breast cancer in early 2026 [1][6] Clinical Development - Cellectar received positive feedback from the EMA's SAWP supporting a Conditional Marketing Authorization filing for iopofosine I 131 based on the CLOVER WaM study [5] - The FDA granted Breakthrough Designation for iopofosine I 131 in relapsed/refractory Waldenstrom's Macroglobulinemia [5] - A Phase 1b clinical study for CLR 125 has been initiated, targeting triple-negative breast cancer [5] Regulatory Milestones - The company plans to submit a CMA application to the EMA for iopofosine I 131 in WM in Q3 2026, with potential approval in early 2027 [6] - Preparations for a New Drug Application (NDA) for U.S. accelerated approval of iopofosine I 131 are underway [6] - The company is actively enrolling patients for the Phase 1b study of CLR 125, with interim data expected in mid-2026 [6] Financial Strategy - Cellectar raised approximately $15.2 million through financings and warrant exercises to support pipeline development and regulatory milestones [5] - The company is focused on disciplined capital management and exploring non-dilutive funding opportunities [7] - The anticipated conditional marketing approval in 2027 from the EMA could impact around thirty countries, potentially expanding the patient population significantly compared to the U.S. [7]

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. is a clinical-stage pharmaceutical company focused on developing targeted radiotherapeutics for central nervous system (CNS) cancers, with an abstract accepted for a poster spotlight presentation at the San Antonio Breast Cancer Symposium [1][2] Group 1: Company Overview - Plus Therapeutics is headquartered in Houston, Texas, and specializes in targeted radiotherapeutics aimed at difficult-to-treat CNS cancers, aiming to enhance clinical outcomes [6][7] - The company is advancing a pipeline of product candidates, particularly in leptomeningeal metastases (LM) and recurrent glioblastoma (GBM) [7] Group 2: Product Information - REYOBIQ (rhenium Re186 obisbemeda) is a novel injectable radiotherapy designed to deliver targeted high-dose radiation to CNS tumors, potentially improving patient outcomes compared to existing therapies [4] - REYOBIQ is currently being evaluated in clinical trials for recurrent glioblastoma, leptomeningeal metastases, and pediatric brain cancer, with significant funding support from various institutions [4] Group 3: Clinical Context - Leptomeningeal metastases (LM) occur in approximately 5% of patients with metastatic cancer, with a median survival of 2-6 months, indicating a critical need for effective treatment options [3] - The CNSide Diagnostics, LLC, a subsidiary of Plus Therapeutics, develops tests to identify tumor cells that have metastasized to the CNS, enhancing patient management for those with LM [5]

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 Insights - CNSide Diagnostics, LLC has signed a national agreement with Humana, Inc. to provide the CNSide Cerebrospinal Fluid Tumor Cell Enumeration laboratory developed test, covering approximately 16 million people in the U.S., increasing total policy coverage to 67 million people [1] - The CNSide CSF Assay Platform supports rapid diagnoses and treatment guidance for patients with leptomeningeal metastases, demonstrating superior clinical utility over standard care as evidenced by multiple peer-reviewed publications and real-world validation [2] - Since 2020, over 11,000 CNSide tests have been performed at more than 120 U.S. cancer institutions, achieving high sensitivity of 92% and specificity of 95%, influencing treatment decisions in 90% of cases [3] Company Overview - CNSide Diagnostics, LLC is a subsidiary of Plus Therapeutics, Inc., focused on developing proprietary laboratory-developed tests to identify tumor cells in patients with central nervous system metastases [4] - Plus Therapeutics, Inc. is a clinical-stage pharmaceutical company based in Houston, Texas, developing targeted radiotherapeutics for challenging cancers of the central nervous system, with a focus on leptomeningeal metastases and recurrent glioblastoma [5] - Humana, Inc. is dedicated to improving health outcomes for its customers through insurance and healthcare services, aiming to enhance the quality of life for various populations including those on Medicare and Medicaid [6]

Core Insights - Plus Therapeutics, Inc. is advancing novel treatments for leptomeningeal metastases (LM) with its products REYOBIQ™ and ReSPECT-LM, showcasing promising clinical trial results at upcoming conferences [1][2] Group 1: Company Overview - Plus Therapeutics is a clinical-stage pharmaceutical company focused on developing targeted radiotherapeutics for central nervous system (CNS) cancers [6] - The company is headquartered in Houston, Texas, and aims to enhance clinical outcomes through innovative therapies [6] Group 2: Product Information - REYOBIQ (rhenium Re186 obisbemeda) is an injectable radiotherapy designed for targeted high-dose radiation in CNS tumors, potentially improving patient outcomes compared to existing therapies [4] - REYOBIQ has received FDA Fast Track and Orphan Drug Designation, with ongoing enrollment in the ReSPECT-LM Dose Optimization Trial [2][4] Group 3: Clinical Trials and Results - The ReSPECT-LM Phase 1 trial demonstrated excellent tolerance of REYOBIQ at higher doses than current standards, indicating a broad therapeutic range [2] - Clinical benefit rate for REYOBIQ exceeded 75% across three relevant outcome measures, with no dose-limiting toxicities observed [6] Group 4: Market Need and Context - Leptomeningeal metastases occur in approximately 5% of metastatic cancer patients, with limited effective treatment options available, highlighting the urgent need for new therapies [3] - Median survival for patients with LM is typically between 2-6 months, underscoring the critical demand for innovative solutions [3]

Core Insights - Plus Therapeutics, Inc. is advancing its clinical-stage pharmaceutical initiatives focused on targeted radiotherapeutics for central nervous system (CNS) cancers, with significant progress in both clinical trials and diagnostic platform technologies [2][8] Corporate Highlights - The company completed a restructuring of a $15 million equity financing, simplifying its capital structure [6] - Plus Therapeutics received an advance payment of $1.6 million from the Cancer Prevention and Research Institute of Texas (CPRIT) as part of a previously awarded $17.6 million grant [6] - The company appointed Kyle Guse, an industry veteran with 30 years of experience, to its Board of Directors [6] - Plus Therapeutics presented updated interim data on its lead compound REYOBIQ™ at a conference, highlighting its safety and clinical benefits for patients with leptomeningeal metastases [6] Clinical Development - The REYOBIQ™ clinical trials are demonstrating favorable safety and efficacy signals, which are facilitating active enrollment in the dose optimization trial [2][4] - The company initiated the ReSPECT-LM dose optimization trial for REYOBIQ, treating the first two patients to evaluate multiple-dose regimens [6] - The U.S. Food and Drug Administration (FDA) cleared the Investigational New Drug (IND) application for REYOBIQ for pediatric patients with specific high-grade gliomas, supported by a $3 million grant from the Department of Defense [6] CNSide CSF Assay Platform - The CNSide CSF assay platform is set to launch in Texas, focusing initially on National Cancer Institute Designated Cancer Centers [10] - The total addressable market for the CNSide CSF Tumor Cell Enumeration (TCE) test is estimated to be $6 billion in the U.S., with plans to add three additional CNS assays [10] - The company aims to expand CNSide testing services regionally over the next 12 months [2][10] Financial Performance - As of June 30, 2025, the company reported cash and investments of $6.9 million, an increase from $3.6 million at the end of 2024 [10] - Grant revenue for Q2 2025 was $1.4 million, compared to $1.3 million in the same quarter of 2024 [10] - The total operating loss for Q2 2025 was $1.5 million, a decrease from $3.7 million in Q2 2024, attributed to improved operational cost control [10] - The company reported a net income of $5.2 million for Q2 2025, a significant turnaround from a net loss of $2.9 million in the same quarter the previous year [10]

Core Insights - Plus Therapeutics, Inc. announced positive data from a retrospective analysis of the CNSide CSF Assay Platform, which can quantify leptomeningeal metastases (LM) and monitor changes in targetable mutations over time [1][2] - The CNSide CSF Assay may catalyze the initiation of LM treatment and enable personalized cancer therapy by allowing real-time adaptation of treatment based on tumor biology [1][3] Company Overview - Plus Therapeutics is a clinical-stage pharmaceutical company focused on developing targeted radiotherapeutics for central nervous system cancers, with a pipeline that includes programs for leptomeningeal metastases and recurrent glioblastoma [6][7] - CNSide Diagnostics, LLC, a subsidiary of Plus Therapeutics, develops proprietary laboratory tests designed to identify tumor cells that have metastasized to the central nervous system [4] Research Findings - The analysis involved 613 CNSide assays ordered for 218 patients, with a significant majority (74%) being female and the most common cancers analyzed being breast (n=105) and lung (n=65) [2] - The CNSide CSF Assay demonstrated a diagnostic sensitivity 2.8 times greater than standard CSF cytology, influencing clinical management decisions in over 90% of LM cases [3][6] - The study found that 67% (412/613) of patients had detectable CSF tumor cells, with notable findings in patients undergoing multiple CSF draws [6] Clinical Implications - The CNSide CSF Assay can detect gene amplification in CSF tumor cells, providing therapeutic insights for targeting LM tumors [3] - Longitudinal analysis using CNSide may offer insights for modifying treatment strategies over time [3] Market Context - Leptomeningeal metastases occur in approximately 5% of patients with metastatic cancer, but postmortem studies suggest the frequency may be as high as 20%, indicating a need for more sensitive diagnostic options [5]