Company: PSTV
Filing Date: 2025-03-31
Form Type: 10-K
Source: 0000950170-25-047698
Chunk: 22

Company: PLUS THERAPEUTICS, INC.
Filing Date: 2025-03-31
Form: 10-K
Item: Item 1
Chunk 22
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 is currently being used in the ReSPECT-LM trial as an exploratory endpoint and we are planning to re-introduce it to the U.S. market starting in the second quarter of 2025. 

In August 2024, data from the CNSideTM  FORESEE clinical trial in patients with LM was presented at the Society for Neuro-Oncology (“SNO”) / American Society for Clinical Oncology (“ASCO”) CNS Metastases Conference. The trial met its key primary and secondary endpoints and the data showed that the CNSideTM Test more than doubled the diagnostic sensitivity versus gold standard cerebrospinal fluid cytology and influenced clinical management decisions in over 90% of LM cases. 

On November 24, 2024, CNSide Diagnostics presented data at the 2024 SNO Annual Meeting from the FORESEE trial showcasing the CNSideTM Platform’s utility in diagnosing and guiding clinical decision making for breast cancer and non-small cell lung cancer patients with LM. 

Key highlights included:

•The FORESEE trial achieved its primary endpoint, demonstrating that the CNSideTM Test influenced treatment decisions in over 90% of cases evaluated, surpassing the predetermined 20% primary endpoint target.

•The CNSideTM Test demonstrated enhanced sensitivity in detecting tumor cells (80%) vs. CSF cytology (29%) in patients with LM.

•The CNSideTM Test identified actionable mutations in the CSF, such as HER2 amplification, influencing 24% of therapeutic selection decisions.

•The CNSideTM Test exhibited high specificity, with no tumor cells detected in patients without LM.

•The CNSideTM Test demonstrated improved Negative Predictive Value in ruling out LM (25%) vs. CSF cytology (10%).

•The CNSideTM Test revealed HER2 positivity in LM tumors in 60% of breast cancer patients with HER2-negative primary tumors, informing physician treatment strategies.

Licensing

On December 31, 2021, we entered into a Patent and Technology License Agreement (the “UTHSCSA License Agreement”) with UTHSCSA, pursuant to which UTHSCSA granted us an irrevocable, perpetual, exclusive, fully paid-up license, with the right to sublicense and to make, develop, commercialize and otherwise exploit certain patents, know-how and technology related to the development of BAM containing nanoliposomes loaded with imaging and/or therapeutic payloads.  Therapeutic payloads may include radiotherapeutics, chemotherapeutics, or thermotherapeutics.  

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