PCVX

EX-99.1

2 pcvx-20260506xexx991.htm

EX-99.1

Document

Exhibit 99.1

Vaxcyte Reports First Quarter 2026 Financial Results and Provides Business Update

Enrollment Now Completed for OPUS-1, OPUS-2 and OPUS-3 Phase 3 Trials Evaluating VAX-31 for the Prevention of Invasive Pneumococcal Disease and Pneumonia in Adults

Topline Safety, Tolerability and Immunogenicity Data from OPUS-1 Expected in Fourth Quarter of 2026; OPUS-2 and OPUS-3 Results Expected in First Half of 2027

Enrollment Completed for VAX-31 Infant Phase 2 Dose-Finding Study; Topline Safety, Tolerability and Immunogenicity Data from Primary Immunization Series and Booster Dose Expected Either Sequentially or Together by End of First Half of 2027

Company Expects to Initiate Phase 1 Adult Clinical Study for VAX-A1, a Vaccine Candidate to Prevent Disease Caused by Group A Strep, in Mid-2026

Approximately $2.7 Billion in Cash, Cash Equivalents and Investments as of March 31, 2026, Including $601.8 Million in Net Proceeds from February 2026 Equity Offering

SAN CARLOS, Calif., May 6, 2026 – Vaxcyte, Inc. (Nasdaq: PCVX), a clinical-stage vaccine innovation company, today announced financial results for the first quarter ended March 31, 2026, and provided a business update.

"With the recent completion of OPUS-3 enrollment, our OPUS-1, OPUS-2 and OPUS-3 adult Phase 3 trials are now fully enrolled, and we remain on track to deliver data from these studies beginning with the expected OPUS-1 topline readout in the fourth quarter," said Grant Pickering, Chief Executive Officer and Co-Founder of Vaxcyte. "Our OPUS Phase 3 program was designed to establish not only a best-in-class pneumococcal conjugate vaccine (PCV), but also a new standard by which other pneumococcal vaccines will be judged. Based on the unprecedented results from our VAX-31 Phase 1/2 study in adults and the advantages of our carrier-sparing platform, we designed the OPUS-1 noninferiority trial as a head-to-head comparison against both Prevnar 20® (PCV20) and Capvaxive® (PCV21) with the potential to deliver a 14-34% increase in coverage against invasive pneumococcal disease (IPD) and a 19-31% increase in coverage against pneumococcal pneumonia relative to the current standard-of-care PCVs in U.S. adults. Following the anticipated OPUS-1 data in the fourth quarter, we expect to announce the results of the OPUS-2 and OPUS-3 Phase 3 trials in the first half of 2027, maintaining the timeline for our planned Biologics Application License (BLA) submission and potential U.S. commercial launch."

"In the first quarter of 2026, we completed an equity financing that further strengthened our balance sheet and extended our cash runway," said Andrew Guggenhime, President and Chief Financial Officer of Vaxcyte. "With $2.7 billion in cash, cash equivalents and investments as of March 31, 2026, we are well positioned to execute on our planned clinical, manufacturing and commercial readiness milestones for our PCV development programs and support the Company’s

next phase of growth. This includes advancing VAX-A1, a prophylactic vaccine candidate designed to prevent disease caused by Group A Strep, into the clinic in mid-2026."

Key First Quarter and Recent Highlights

PCV Franchise Adult Indication:

Advanced Comprehensive VAX-31 Phase 3 Adult Clinical Program to Support Planned BLA Submission, with Enrollment Completed for Three OPUS Trials: All three ongoing VAX‑31 Phase 3 clinical trials (OPUS-1, OPUS-2 and OPUS-3) are now fully enrolled with 6,191 adults dosed in total, approximately 3,500 of whom received VAX-31. These studies, which were finalized in consultation and alignment with the U.S. Food and Drug Administration (FDA), are designed to generate a broad and robust safety, tolerability and immunogenicity dataset. In addition, the Company is also planning a manufacturing consistency study (e.g., a lot-to-lot study) as the final Phase 3 study.

•In March 2026, the Company announced the completion of enrollment in the OPUS-1 Phase 3 pivotal, noninferiority trial with 4,049 participants dosed and the OPUS-2 Phase 3 trial evaluating VAX-31 concomitantly administered with a seasonal influenza vaccine with 1,390 participants dosed. OPUS-1 is evaluating the safety, tolerability and immune responses of VAX-31 in healthy, pneumococcal-naïve1 adults aged 50 and older through direct, head-to-head comparisons with both PVC20 and PCV21, the current standard-of-care PCVs, with the objective of establishing a best-in-class profile for VAX-31. The trial is also evaluating the safety, tolerability and immune responses of VAX-31 in a separate cohort of adults aged 18-49. OPUS-2 is evaluating the safety, tolerability and immunogenicity of VAX-31 when administered either concomitantly with or one month following administration of a licensed seasonal influenza vaccine in pneumococcal-naïve, healthy U.S. adults aged 50 years and older. The results of this descriptive study are intended to inform the design of a potent

pcvx-202602240001649094FALSE00016490942026-02-242026-02-24

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): February 24, 2026

Vaxcyte, Inc. (Exact name of Registrant as Specified in Its Charter)

Delaware01-3932346-4233385 (State or Other Jurisdiction of Incorporation)(Commission File Number)(IRS Employer Identification No.)

825 Industrial Road Suite 300 San Carlos , California 94070 (Address of Principal Executive Offices)(Zip Code)

Registrant’s Telephone Number, Including Area Code: (650) 837-0111 Not Applicable (Former Name or Former Address, if Changed Since Last Report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

oWritten communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

oSoliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

oPre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

oPre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class Trading Symbol(s) Name of each exchange on which registered

Common Stock, $0.001 par value per sharePCVXThe Nasdaq Stock Market LLC

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter). Emerging growth company o If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. o

Item 2.02 Results of Operations and Financial Condition. On February 24, 2026, Vaxcyte, Inc. issued a press release announcing its financial results for the quarter and full year ended December 31, 2025. The full text of the press release is furnished as Exhibit 99.1 to this report on Form 8-K and is incorporated herein by reference. The information in this Item 2.02 and Item 9.01, including 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 9.01 Financial Statements and Exhibits. (d)Exhibits

Exhibit NumberDescription 99.1Press Release of Vaxcyte, Inc., dated February 24, 2026

104Cover Page Interactive Data File (embedded within the Inline XBRL document)

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

VAXCYTE, INC.

Date:February 24, 2026By: /s/ Andrew Guggenhime Andrew Guggenhime President and Chief Financial Officer

pcvx-202511040001649094FALSE00016490942025-11-042025-11-04

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): November 4, 2025

Vaxcyte, Inc. (Exact name of Registrant as Specified in Its Charter)

Delaware01-3932346-4233385 (State or Other Jurisdiction of Incorporation)(Commission File Number)(IRS Employer Identification No.)

825 Industrial Road Suite 300 San Carlos , California 94070 (Address of Principal Executive Offices)(Zip Code)

Registrant’s Telephone Number, Including Area Code: (650) 837-0111 Not Applicable (Former Name or Former Address, if Changed Since Last Report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

oWritten communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

oSoliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

oPre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

oPre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class Trading Symbol(s) Name of each exchange on which registered

Common Stock, $0.001 par value per sharePCVXThe Nasdaq Stock Market LLC

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter). Emerging growth company o If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. o

Item 2.02 Results of Operations and Financial Condition. On November 4, 2025, Vaxcyte, Inc. issued a press release announcing its financial results for the quarter ended September 30, 2025. The full text of the press release is furnished as Exhibit 99.1 to this report on Form 8-K and is incorporated herein by reference. The information in this Item 2.02 and Item 9.01, including 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 9.01 Financial Statements and Exhibits. (d)Exhibits

Exhibit NumberDescription 99.1Press Release of Vaxcyte, Inc., dated November 4, 2025

104Cover Page Interactive Data File (embedded within the Inline XBRL document)

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

VAXCYTE, INC.

Date:November 4, 2025By: /s/ Andrew Guggenhime Andrew Guggenhime President and Chief Financial Officer