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- Going Concern (worsened) — Current filing states substantial doubt about ability to continue as going concern despite January 2026 capital raise extending runway to 2027, indicating heightened urgency versus baseline.
- Auditor Change (new) — CBIZ CPAs P.C. replaced BDO USA as auditor effective 2025, with new critical audit matter identified on warrant valuation complexity.
- Material Weakness (removed) — Baseline disclosed material weakness in grant revenue controls identified Q2 2023 and remediated Q1 2024; current filing omits this discussion entirely.
revenue $5.2M, net income -$22.4M. Plus Therapeutics launches CNSide diagnostics, secures 67M covered lives; FDA rejects CTC endpoint for LM drug trial
Filed March 12, 2026 · Period ending December 31, 2025 · Compared to 10-K Mar 31, 2025 · ~2 min read
Key Changes
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FDA rejected circulating tumor cells as primary endpoint for leptomeningeal metastases trial in November 2025, requiring overall survival endpoint instead—materially extending development timeline and trial costs versus prior accelerated approval strategy.
MD&A: FDA Feedback verify on EDGAR → -
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CNSide diagnostic test launched commercially in August 2025 with CLIA certification and national payor agreements covering 67 million lives (UnitedHealthcare, Humana); obtained 49-state licensure by January 2026.
Business: CNSide Launch verify on EDGAR → -
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Company raised $22.6M through Lincoln Park equity facility and $13.3M in January 2026 public offering, but issued 50M shares under Lincoln Park alone—approximately 23x dilution year-over-year from 5.9M to 138.7M shares outstanding.
Notes: Equity Financings verify on EDGAR →
2 more material changes behind this preview — plus the full narrative summary, section-by-section diffs against the prior filing, and verbatim quotes with EDGAR citations.
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Figures/quotes linked to EDGAR · Narrative written by AI · Jun 8, 2026 · How we verify