Plus Therapeutics Inc - PSTV STOCK NEWS

Plus Therapeutics (NASDAQ: PSTV) has announced key leadership appointments for its CNSide Diagnostics subsidiary. Russell Bradley has been named President and General Manager, bringing over 30 years of leadership experience in diagnostics from companies like Abbott Laboratories, Luminex , and Beckman Coulter.

The company has also appointed Dr. Marc Hedrick, Rick Hawkins, and Russell Bradley to the CNSide Board of Directors. Additionally, Dr. Jonathan Stein has been appointed as CNSide Medical Director, bringing 20 years of expertise in molecular diagnostics, assay development, and regulatory compliance.

CNSide Diagnostics plans to begin a pilot market introduction this quarter, focusing on developing improved tools for testing and treating leptomeningeal disease. The subsidiary aims to secure full capitalization to support early access and initial launch plans in the U.S.

Plus Therapeutics (PSTV) has appointed Dr. Michael Rosol as Chief Development Officer to lead the company's clinical, pre-clinical, and biomarker development activities. Dr. Rosol brings 25 years of experience in clinical trial design, operations, and regulatory execution to the company, which is preparing to move from mid-stage to pivotal trials next year.

Previously serving as Chief Medical Officer and Senior Vice President at Navidea Biopharmaceuticals, Dr. Rosol also worked at Novartis Pharmaceuticals leading biomarker development and translational imaging groups. His academic background includes a Ph.D. from Boston University focusing on biomedical and radionuclide imaging, and appointments at prestigious institutions including Harvard Medical School/Massachusetts General Hospital and Mayo Clinic.

Plus Therapeutics (PSTV) has secured $5.7 million in financing through two sources: a $3.7 million private placement from existing investors and a $2.0 million advance payment from the Cancer Prevention and Research Institute of Texas (CPRIT). The funding will support the clinical development of Rhenium (186Re) Obisbemeda for leptomeningeal metastases (LM) and the development of CNSide LM diagnostic test.

The private placement includes secured convertible promissory notes totaling $3,362,251 and warrants to purchase up to 3,002,009 shares at $1.12 per share. The notes mature in one year, bear 10% annual interest, and are convertible into common stock. The $2.0 million CPRIT advance is part of an existing $17.6 million grant, with approximately $5.2 million remaining.

Additionally, the company issued Exchange Notes worth $3,188,922 in exchange for canceling 3,543,247 Series A warrants from May 2024.

Plus Therapeutics (PSTV) presented interim Phase 1 data for its ReSPECT-LM clinical trial of Rhenium Obisbemeda in leptomeningeal metastases, focusing on breast cancer patients. Nine of 20 patients with LM primary breast cancer were treated across five dose escalation cohorts. The treatment showed promising results with 88% circulating tumor cell response rate and 75% MRI imaging clinical benefit rate. Only one dose-limiting toxicity was reported, and the median overall survival was 9 months, with 2 patients surviving beyond 600 days. The company plans to initiate a Phase 1b single-dose breast expansion cohort in Q1 2025.

Plus Therapeutics (PSTV) will present Phase 1 interim data for its ReSPECT-LM trial at the 2024 San Antonio Breast Cancer Symposium. The presentation will focus on Rhenium (186Re) Obisbemeda treatment for leptomeningeal metastases (LM) in breast cancer patients.

The presentation, led by Dr. Andrew Brenner from the University of Texas Health Science Center, is scheduled for December 13, 2024. LM is a rare but serious cancer complication affecting the cerebrospinal fluid and leptomeninges, with breast cancer being the most common primary cancer leading to LM. The condition affects 3-5% of breast cancer patients and has a poor prognosis, with 1-year and 2-year survival rates of only 7% and 3%, respectively. Currently, there are no FDA-approved therapies specifically for LM.

Plus Therapeutics (Nasdaq: PSTV) has renewed its Master Services Agreement with Telix IsoTherapeutics Group for the supply of cGMP rhenium-186 (Re-186), a key radioisotope used in their lead radiotherapeutic candidate Rhenium (186Re) Obisbemeda. The five-year renewable agreement ensures reliable supply for late-stage clinical trials and commercial needs. This agreement complements their partnership with SpectronRx for final drug manufacturing, establishing a comprehensive end-to-end supply chain. The agreement focuses on producing aluminum perrhenate radionuclide intermediate and final processing of cGMP Re-186, enabling scalable, just-in-time manufacturing.

Plus Therapeutics (PSTV) presented positive interim data from its ReSPECT-LM Phase 1 trial of Rhenium (186Re) Obisbemeda for leptomeningeal metastases at the 2024 SNO Annual Conference. The trial, involving 20 patients through Cohort 5, demonstrated a 93% response rate in circulating tumor cells, 75% in MRI imaging, and 86% in clinical response. The treatment showed a favorable safety profile with only one dose-limiting toxicity. Median overall survival for Cohorts 1-4 was 9 months, with 6 out of 16 patients alive at analysis. The FDA has agreed to initiate a multiple administration dose escalation trial, with enrollment expected in early 2025.

Plus Therapeutics announced positive results from the FORESEE clinical trial evaluating CNSide™ Cerebrospinal Fluid Assay for leptomeningeal metastases (LM). The trial met its primary endpoint, with CNSide influencing treatment decisions in over 90% of cases. The assay showed 80% sensitivity in detecting tumor cells compared to 29% for standard CSF cytology. Notable findings include CNSide's ability to identify actionable mutations and its revelation of HER2 positivity in 60% of breast cancer patients with HER2-negative primary tumors, significantly impacting treatment strategies.

Plus Therapeutics will present data at the 2024 Society for NeuroOncology Annual Meeting showcasing their CNSide CSF Assay Platform's effectiveness in analyzing leptomeningeal metastases (LM). The study examined 258 CSF samples from 66 LM patients across five institutions.

The analysis revealed significant findings: 88% of patients showed biomarker changes through FISH analysis, with 26 new actionable biomarkers identified. Additionally, 20% of patients demonstrated biomarker changes through ICC analysis, discovering 7 new actionable biomarkers. The research evaluated 14 biomarkers total, with 12 showing changes during treatment.

These findings suggest dynamic mutation profiles in LM, highlighting potential implications for treatment strategies, particularly regarding radiotherapeutics like Rhenium Obisbemeda.