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Standing Risk Factors

  • Section 232 Pharmaceutical Tariff Investigation (unchanged) — U.S. government announced plans for 100% tariff on patented drugs/ingredients manufactured outside the U.S.; company relies on third-party manufacturers with global operations and cannot pass costs to customers (no commercial products yet).
  • Vax-31 Adult Phase 3 Non-inferiority Threshold Raised to 0.667 (unchanged) — FDA set a more stringent non-inferiority standard (0.667 vs. historical 0.50) for the pivotal OPUS-1 trial, making it harder to demonstrate non-inferiority to existing vaccines.
NASDAQ: PCVX Vaxcyte, Inc. 10-Q

net income -$284.3M. Operating loss widens 34% as VAX-31 Phase 3 completes enrollment; Lonza suite goes live

Filed August 5, 2026 · Period ending June 30, 2026 · Compared to 10-Q Aug 6, 2025 · ~1 min read

Key Changes

  • high

    All three VAX-31 adult Phase 3 trials (OPUS-1, OPUS-2, OPUS-3) fully enrolled with 6,191 participants, ~3,500 receiving VAX-31, advancing the adult PCV program toward BLA submission.

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

    Lonza's Visp manufacturing suite handed over to operations Aug 1, 2026, transitioning from construction to commercial-scale production capability for PCV components.

    MD&A & Notes: Lonza Suite view on EDGAR →
  • high

    Operating loss widened from -$226.2M to -$302.8M YoY (34%), driven by$$197.5M increase in R&D expenses (manufacturing +$127M, clinical trials +$70.5M) and $56M decline in other income (FX gains reversed, interest income fell).

    MD&A: Operating Results verify on EDGAR →

1 more material change 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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View original filing on SEC.gov View full financials on EDGAR ↗

Figures/quotes linked to EDGAR · Narrative written by AI · Aug 6, 2026 · How we verify