Plus Therapeutics launches CNSide diagnostics, secures major payor deals; FDA requires survival endpoint for LM trial

Filed May 15, 2026 · Period ending March 31, 2026 · Compared to 10-Q May 30, 2025 · ~2 min read

Key Changes

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  CNSide diagnostics began commercial billing in Q1 2026 with national payor agreements from UnitedHealthcare, Humana, Highmark, and Blue Shield of California. Revenue was immaterial but expected to grow through 2026 as reimbursement codes were approved in April.

  MD&A: CNSide commercial launch verify on EDGAR →
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  FDA rejected circulating tumor cells as primary endpoint for accelerated approval in leptomeningeal metastases, requiring overall survival endpoint instead. This necessitates a longer, more complex randomized controlled trial versus intrathecal chemotherapy comparator.

  MD&A: FDA feedback on LM endpoint verify on EDGAR →
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  January 2026 public offering raised $13.9 million net proceeds at $9.50 per share/warrant unit, improving working capital from $0.3 million to $10.1 million year-over-year and extending cash runway.

  MD&A: January 2026 public offering verify on EDGAR →