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- Material Weakness (worsened) — Material weakness now explicitly includes failure across all five COSO principles, indicating broader control deficiencies than previously disclosed.
Spectral AI revenue falls 40% as BARDA contract winds down; FDA submission complete
Filed May 13, 2026 · Period ending March 31, 2026 · Compared to 10-Q May 15, 2025 · ~1 min read
Key Changes
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Revenue declined 40.5% to $4.0M as BARDA contract neared base-phase completion; operating loss widened to $2.0M from $0.9M prior year. Company swung from $2.9M profit to $3.4M loss, though prior profit included $4.3M non-cash warrant gain.
MD&A: Financial Results verify on EDGAR → -
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FDA De Novo submission for DeepView AI-Burn completed June 2025; validation study (164 patients) showed superiority in sensitivity vs. clinician assessment. Regulatory clearance would enable U.S. commercialization.
MD&A: Regulatory Milestones verify on EDGAR → -
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BARDA accelerated $31.7M in funding (March 2026) for follow-on development and procurement, extending base phase to June 2026. Company committed to co-fund $9.7M of total development costs.
MD&A: BARDA Contract 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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Generated by AI · Jun 1, 2026 1:16 PM