Vaxcyte Reports Third Quarter 2026 Financial Results and Provides Business Update
Key Highlights
- ➤VAX-31 met all prespecified OPUS-1 Phase 3 primary immunogenicity endpoints in adults
- ➤VAX-31 showed safety similar to PCV20 and PCV21 across all ages studied
- ➤OPUS-2 and OPUS-3 Phase 3 results expected in first half of 2027
- ➤Vaxcyte expects VAX-31 adult BLA submission in first half of 2028
- ➤October offerings generated approximately $1.1 billion net proceeds; pro forma liquidity reached $3.4 billion
Expert Statements
Grant Pickering, Chief Executive Officer and Co-Founder of Vaxcyte
“The positive topline results from OPUS-1 represent a significant milestone for Vaxcyte and our broad-spectrum pneumococcal conjugate vaccine (PCV) franchise”
Grant Pickering, Chief Executive Officer and Co-Founder of Vaxcyte
“VAX-31 met all prespecified primary endpoints in this pivotal Phase 3 trial, which inaugurated a more stringent noninferiority standard, and we believe the results further support its potential best-in-class profile.”
Grant Pickering, Chief Executive Officer and Co-Founder of Vaxcyte
“With OPUS-1 serving as the foundation of our planned Biologics License Application (BLA), we remain on track to announce results from the OPUS-2 and OPUS-3 Phase 3 trials in the first half of next year and, together with a manufacturing consistency study, we expect to submit a BLA in the first half of 2028.”
Grant Pickering, Chief Executive Officer and Co-Founder of Vaxcyte
“For the VAX-31 infant indication, we expect to announce topline data from the primary immunization series and booster dose of the ongoing Phase 2 study, either sequentially or together, by the end of the first half of 2027.”
Andrew Guggenhime, President and Chief Financial Officer of Vaxcyte
“Following our positive OPUS-1 results, we completed concurrent equity and convertible senior notes offerings, raising approximately $1.1 billion in net proceeds, to further strengthen our balance sheet and extend our cash runway”
Andrew Guggenhime, President and Chief Financial Officer of Vaxcyte
“With approximately $3.4 billion in pro forma cash, cash equivalents and investments as of September 30, 2026, we are well positioned to support the potential U.S. commercial launch of VAX-31 for adults and advance our other key initiatives, including the VAX-31 OPUS-2 and OPUS-3 adult Phase 3 studies, the VAX-31 infant Phase 2 study, scale-up of our manufacturing and supply chain, and our earlier stage pipeline including VAX-A1 and VAX-XL.”
VAX-31 Adult Indication: Announced Positive Topline Data from OPUS-1 Pivotal Phase 3 Trial; VAX-31 Met All Prespecified Primary Endpoints, Was Well Tolerated and Demonstrated a Safety Profile Similar to PCV20 and PCV21 Across All Ages Studied
VAX-31 Adult Indication: Company Expects to Report Results from OPUS-2 and OPUS-3 Phase 3 Trials in First Half of 2027, Supporting Planned Biologics License Application Submission in First Half of 2028
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