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Get filing alertsVaxcyte completes enrollment in three VAX-31 Phase 3 trials, reports $2.5B cash
Filed August 5, 2026 · Period ending August 5, 2026 · ~1 min read
Key Changes
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Completed enrollment in all three VAX-31 adult Phase 3 trials (OPUS-1, OPUS-2, OPUS-3), dosing 6,191 adults with ~3,500 receiving VAX-31. Pivotal OPUS-1 trial compares VAX-31 head-to-head against Prevnar 20 and Capvaxive; topline data expected Q4 2026.
Exhibit 99.1 view on EDGAR → -
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Cash and investments totaled $2.5B as of June 30, 2026, up from $2.4B at year-end 2025. Q2 net loss widened to $284.3M from $166.6M year-over-year, driven by increased R&D spending ($267.9M vs. $194.2M) for Phase 3 trials and manufacturing.
Exhibit 99.1 view on EDGAR → -
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Initiated Phase 1 study for VAX-A1, a Group A Streptococcus vaccine candidate, dosing first participant in June 2026. All Stage 1 participants have received first of two planned doses; topline data expected H2 2027.
Exhibit 99.1 view on EDGAR → -
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Expects topline data from VAX-31 infant Phase 2 dose-finding study (primary series and booster) by end of H1 2027, a key milestone for the infant indication development program.
Exhibit 99.1 view on EDGAR → -
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Appointed Dr. Moncef Slaoui (former Operation Warp Speed Chief Scientific Advisor) and Dr. John Markels (former Merck Global Vaccines President) to the Board, replacing retiring members Jacks Lee and Dr. Heath Lukatch.
Exhibit 99.1 view on EDGAR →
Summary
Vaxcyte reported Q2 2026 results highlighting completion of enrollment in all three VAX-31 adult Phase 3 trials, a critical milestone for its lead pneumococcal conjugate vaccine program. The company dosed 6,191 adults across OPUS-1, OPUS-2, and OPUS-3, with approximately 3,500 receiving VAX-31.
The pivotal OPUS-1 trial directly compares VAX-31 against current standard-of-care vaccines Prevnar 20 and Capvaxive in 4,049 participants, with topline data expected in Q4 2026. This head-to-head design positions the company to demonstrate differentiation in a competitive adult pneumococcal vaccine market.
Financially, Vaxcyte ended the quarter with $2.5 billion in cash and investments, providing runway to advance its pipeline. The Q2 net loss of $284.3 million, up from $166.6 million year-over-year, reflects increased investment in Phase 3 trial execution and manufacturing readiness. R&D expenses rose to $267.9 million from $194.2 million, driven by VAX-31 development costs. The company also initiated a Phase 1 study for VAX-A1, a Group A Streptococcus vaccine candidate, expanding its infectious disease portfolio. Key catalysts to watch include Q4 2026 OPUS-1 topline data, H1 2027 OPUS-2/OPUS-3 results, and H1 2027 VAX-31 infant Phase 2 data.
Section-by-Section Diff
Event · Item 2.02 — Results of Operations and Financial Condition
Vaxcyte announced Q2 2026 financial results via press release.
Added in current filing · verify on EDGAR →
On August 5, 2026, Vaxcyte, Inc. issued a press release announcing its financial results for the quarter ended June 30, 2026.
Vaxcyte disclosed its second quarter 2026 financial results through a press release. The 8-K body does not provide specific financial figures; those would be contained in the referenced Exhibit 99.1 press release, which is not included in the provided text.
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Figures/quotes linked to EDGAR · Narrative written by AI · Aug 6, 2026 · How we verify