Current Report · Items 7.01, 8.01, 9.01 · 8-K

Vaxcyte, Inc.

PCVXNASDAQEQUITYCurrent

Regulation FD Disclosure · Other Events

Filed Oct 5, 2026Accepted Oct 5, 2026, 8:01 AM EDTCIK 1649094Accession 0001193125-26-413168

Press release in this filing

Vaxcyte Reports Positive Topline Data from OPUS-1, the Pivotal Adult Phase 3 →

Company context

Vaxcyte is a vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases. VAX-31, a 31-valent PCV candidate being evaluated in the OPUS Phase 3 adult clinical program and in a Phase 2 infant clinical program, is being developed for the prevention of IPD and is the broadest-spectrum PCV candidate in the clinic today. VAX-24, a 24-valent PCV candidate, has generated positive Phase 2 clinical results in both adults and infants and is designed to cover more serotypes than any PCV on-market. VAX-31 and VAX-24 are designed to improve upon standard-of-care PCVs by covering the serotypes in circulation that cause a significant portion of IPD and are associated with high case-fatality rates, antibiotic resistance and meningitis, while maintaining coverage of previously circulating strains. VAX-XL, in earlier-stage development, also leverages the Company’s carrier-sparing, site-specific conjugation technology with the aim of further expanding coverage to deliver the broadest-spectrum candidate in the Company’s PCV franchise.

Current securities

PCVXNASDAQ · EQUITY · Current

Recent company filings

Registered securities in this filing

Vaxcyte, Inc. · 8-K · Filed 2026-10-05

As filed in this accession. Current/historical status below comes from the governed listing record; the cover itself remains exact to this filing.

Common Stock, $0.001 par value per share

Symbol: PCVX
Exchange: NASDAQ
Classification: COMMON
Status: Current

Filing context

Context: duration_2026-10-05_to_2026-10-05

Dimensions: Not supplied

Accession 000119312526413168 · 1 registered-security cover member

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Disclosure sections

Items 7.01, 8.01, 9.01

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Item 7.01Item 7.01 - Regulation FD Disclosure

Item 7.01. Regulation FD Disclosure. On October 5, 2026, Vaxcyte, Inc. (the “Company”) issued a press release announcing positive topline data from its Phase 3 OPUS-1 pivotal adult trial evaluating the safety, tolerability and immunogenicity of VAX-31, the Company’s 31-valent pneumococcal conjugate vaccine candidate designed to prevent invasive pneumococcal disease and pneumococcal pneumonia. The press release is attached as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference. Exhibit 99.1 shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference into any registration statement or other document filed under the Securities Act of 1933, as amended or the Exchange Act, except as shall be expressly set forth by specific reference in such filing.

Item 8.01Item 8.01 - Other Events

Item 8.01. Other Events. On October 5, 2026, the Company also made available the slide presentation attached as Exhibit 99.2 to this Current Report on Form 8-K, which is incorporated herein by reference.

Filed exhibits (2)

EX-99.1 (by filename) d21202dex991.htm

Exhibit 99.1 Vaxcyte Reports Positive Topline Data from OPUS-1, the Pivotal Adult Phase 3 Trial of VAX-31, the Company’s 31-Valent Pneumococcal Conjugate Vaccine Candidate VAX-31 Met All Prespecified Primary Endpoints Across Age Groups Studied Compared to Prevnar 20® (PCV20) and/or Capvaxive® (PCV21) Prespecified Co-Primary Immunogenicity Endpoints: In Adults 50 and Older, All 28 VAX-31 Serotypes Shared with PCV20 and/or PCV21 Met Noninferiority Criterion at >0.667 Threshold; All Three Serotypes Unique to VAX-31 and Cross-Reactive Serotype 20B Met Superiority Criterion Prespecified Primary Immunobridging Endpoint: Across All 321 Serotype Comparisons, VAX-31 Met Noninferiority Criterion at >0.667 Threshold in Adults Aged 18-49 Compared with Adults Aged 50-64 Prespecified Primary Safety Endpoint: VAX-31 Was Well Tolerated and Demonstrated a Safety Profile Similar to PCV20 and PCV21 Across All Ages Studied Prespecified Individual Comparator Results: VAX-31 Met Noninferiority Criterion at >0.667 Threshold for 20 of 20 Serotypes Shared with PCV20 and 17 of 19 Shared with PCV21, and at Historical >0.5 Threshold, VAX-31 Met Noninferiority Criterion for 19 of 19 Shared with PCV212 …

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EX-99.2 (by filename) d21202dex992.htm

October 5, 2026 VAX-31 OPUS-1 Pivotal Phase 3 Adult Trial: Topline Results Exhibit 99.2 October 5, 2026 Strong Track Record in Vaccines and Biopharma Grant Pickering, MBA Chief Executive Officer, Director & Co-Founder Andrew Guggenhime, MBA President & Chief Financial Officer Jim Wassil, MS, MBA Executive VP, Chief Operating Officer & Chief Scientific Officer Luis Jodar, PhD Chief Medical Officer Mike Mullette, MBA Chief Commercial Officer Vaxcyte Leadership Team on Today’s Call Forward-Looking Statements October 5, 2026 This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements related to the potential benefits of Vaxcyte’s carrier-sparing platform and vaccine candidates, including breadth of coverage and the ability to deliver potentially better immune responses, best-in-class vaccines and the improvement upon the standard-of-care; demand for Vaxcyte’s vaccine candidates; the design, timing of initiation, progress and expected results of Vaxcyte’s preclinical studies, clinical trials and research and development plans; the ability of Vaxcyte’s cell…