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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 (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.
Plus Therapeutics reported Q3 2024 financial results and business updates. Key highlights include FDA agreement to start a Phase 1 trial for Rhenium (186Re) Obisbemeda in leptomeningeal metastases treatment, positive ReSPECT-GBM trial data presentation, and a new manufacturing partnership with SpectronRx. Financial results show cash balance of $4.8M as of September 30, 2024, grant revenue of $4.4M YTD, and operating loss of $10.8M. The company received a $0.9M DoD grant payment and expects a $3.9M CPRIT grant advance within 90 days.
Plus Therapeutics (Nasdaq: PSTV) and SpectronRx have signed a Manufacturing Services Agreement for the production of Rhenium (186Re) Obisbemeda, a radiotherapy for CNS cancers. SpectronRx will utilize its facilities to produce late-stage clinical and commercial supplies of the treatment. The partnership aims to expand Plus' manufacturing capabilities and strengthen supply chain redundancy for upcoming late-stage clinical trials in 2025. SpectronRx operates across five locations with over 170,000 sq ft of radiopharmaceutical manufacturing space and 150 employees, serving 29 countries and collaborating with 31 pharmaceutical companies.
Plus Therapeutics (PSTV), a clinical-stage pharmaceutical company focused on targeted radiotherapeutics for central nervous system cancers, has scheduled its third quarter 2024 financial results announcement for Thursday, November 14, 2024, after market close. The management team will host a conference call and webcast at 5:00 p.m. ET to discuss the results and provide a corporate update. Participants can pre-register through the provided dial-in link and access the webcast through the company's website, where it will remain available for 90 days following the live call.
Plus Therapeutics (PSTV) will present multiple data sets at the 2024 Society for Neuro-Oncology Annual Meeting in Houston, Texas, November 21-24, 2024. The presentations will focus on their leptomeningeal metastases (LM) programs, including results from the ReSPECT-LM Phase 1 clinical trial of Rhenium Obisbemeda and the FORESEE Trial of circulating tumor cells. The company will also host an educational symposium titled 'Novel Targeted Radiotherapies to Manage Leptomeningeal Metastases' featuring clinical experts discussing LM therapeutic and diagnostic programs.
Plus Therapeutics presented an update on the ReSPECT-GBM Phase 1/2 clinical trial for Rhenium (186Re) Obisbemeda in recurrent glioblastoma at the 2024 Congress of Neurological Surgeons Annual Meeting. Key highlights include:
- 42 patients enrolled, with 19 treated at the recommended Phase 2 dose
- Favorable safety profile observed
- Mean Phase 2 absorbed dose was 300 Gy
- 89% of patients exceeded the minimal dose threshold of 100 Gy
- Statistically significant reduction in tumor volume rate change for tumors receiving >100 Gy absorbed dose
- Trial expanded to two new sites at leading U.S. academic medical centers
The data suggests continued safety and potential efficacy of Rhenium (186Re) Obisbemeda in patients with recurrent glioblastoma, supporting its advancement as a promising therapeutic option.
Plus Therapeutics (Nasdaq: PSTV) will present new interim data from its ReSPECT-GBM Phase 2 trial at the 2024 Congress of Neurological Surgeons Annual Meeting. The presentation, titled "Treatment of Recurrent Glioblastoma (rGBM) via Convection Enhanced Delivery (CED) with Rhenium (186Re) Obisbemeda (Rhenium-186 Nanoliposome, 186RNL): ReSPECT-GBM Phase 2 Trial Update," will be given by Dr. John Floyd on September 30, 2024. This showcases progress in Plus Therapeutics' program for recurrent glioblastoma, using targeted radiotherapeutics with advanced platform technologies for central nervous system cancers.
Plus Therapeutics (Nasdaq: PSTV), a clinical-stage pharmaceutical company focused on developing targeted radiotherapeutics for central nervous system (CNS) cancers, has announced its participation in the H.C. Wainwright 26th Annual Global Investment Conference. The event is scheduled for September 9-11, 2024, at the Lotte New York Palace Hotel.
Key details:
- Marc H. Hedrick, M.D., President and CEO of Plus Therapeutics, will present a corporate overview
- The presentation will be available on-demand starting September 9, 2024, at 7:00 AM ET
- A replay will be accessible for 90 days on the company's website
- Management will be available for one-on-one meetings during the conference
Investors and interested parties can access the webcast and register for the conference through the provided links.
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