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NASDAQ: PCVX Vaxcyte, Inc. 10-Q

Vaxcyte completes Phase 3 enrollment for VAX-31, raises $632M, but burn accelerates 111%

Filed May 6, 2026 · Period ending March 31, 2026 · Compared to 10-Q May 7, 2025 · ~2 min read

Key Changes

  • high

    Completed enrollment in three VAX-31 adult Phase 3 trials (OPUS-1, OPUS-2, OPUS-3) dosing 6,191 participants; OPUS-1 topline data expected Q4 2026. FDA expanded breakthrough therapy designation to include pneumonia prevention, broadening potential commercial label beyond invasive disease.

    MD&A: VAX-31 Phase 3 milestones verify on EDGAR →
  • high

    R&D expenses surged 111% year-over-year to $312.8M in Q1 2026, driven by $101.8M increase in manufacturing costs (commercial launch prep) and $45.0M increase in clinical trial costs. Cash position declined from $3.0B to $2.7B despite $632.5M February equity raise, reflecting peak Phase 3 spending.

    MD&A: R&D expense and cash burn verify on EDGAR →
  • high

    U.S. government announced plans for 100% tariff on patented pharma products manufactured outside the U.S. under Section 232 investigation. Company relies on third-party manufacturers with global operations and cannot pass costs to customers (no commercial products yet), creating new expense risk.

    Risk Factors: Tariff risk 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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