Vaxcyte Reports First Quarter 2025 Financial Results and Provides Business Update

-- Company Reported Positive Topline Safety, Tolerability and Immunogenicity Data from Phase 2 Dose-Finding Study of VAX-24 in Healthy Infants; Balance of Data Expected by End of 2025 --

-- Initiated Second and Final Stage of VAX-31 Infant Phase 2 Dose-Finding Study; Topline Safety, Tolerability and Immunogenicity Data from Primary Three-Dose Immunization Series Expected in Mid-2026, With Complete Booster Data Up to Nine Months Later --

-- Company Expects to Initiate VAX-31 Adult Phase 3 Pivotal, Non-Inferiority Study by Mid-2025 and Announce Topline Safety, Tolerability and Immunogenicity Data in 2026 --

SAN CARLOS, Calif., May 07, 2025 (GLOBE NEWSWIRE) -- Vaxcyte, Inc. (Nasdaq: PCVX), a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases, today announced financial results for the first quarter ended March 31, 2025, and provided a business update.

“We continue to make meaningful progress across our pneumococcal conjugate vaccine (PCV) candidates, with each milestone bringing us closer to potentially delivering the broadest-spectrum PCVs to address the substantial invasive pneumococcal disease burden in both adults and infants,” said Grant Pickering, Chief Executive Officer and Co-founder of Vaxcyte. “For the adult indication, we expect to initiate the VAX-31 adult Phase 3 pivotal, non-inferiority study by the middle of this year with topline data expected next year. For the pediatric indication, we expect to announce the balance of the VAX-24 infant Phase 2 dose-finding study data by the end of 2025 and share topline data from the VAX-31 infant Phase 2 dose-finding study primary immunization series in mid-2026, followed by complete booster data up to nine months later. Pending the VAX-31 infant study readout, we plan to initiate a Phase 3 program with an optimized dose formulation of VAX-24 or VAX-31.”

“With a strong balance sheet totaling approximately $3.0 billion in cash, cash equivalents and investments, we are well-positioned to continue advancing our PCV pipeline, which we believe has the potential to redefine the standard of protection against devastating diseases caused byStreptococcus pneumoniae,” said Andrew Guggenhime, President and Chief Financial Officer of Vaxcyte. “As we enter this next chapter of growth within a dynamic macro environment, we are evaluating our investment priorities and allocation of capital to ensure the continued strength of our balance sheet and to deliver on the promise of our PCV franchise.”

PCV Franchise Infant IndicationThe Company plans to initiate an infant Phase 3 program with an optimized dose formulation of VAX-24 or VAX-31, pending the VAX-31 topline Phase 2 dose-finding study readout.

Company management will participate in fireside chats and host one-on-one meetings at the following investor conferences. A live webcast of the fireside chats will be accessible through the Investors & Media section of the Company’s website athttp://investors.vaxcyte.comfor approximately 30 days following each conference.

About VaxcyteVaxcyte is a vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases. The Company is developing broad-spectrum conjugate and novel protein vaccines to prevent or treat bacterial infectious diseases. VAX-31, a 31-valent PCV candidate advancing to a Phase 3 adult clinical program and currently being evaluated in a Phase 2 infant clinical program, is being developed for the prevention of IPD in adults and infants and is the broadest-spectrum PCV candidate in the clinic today. VAX-24, the Company’s 24-valent PCV candidate, is designed to cover more serotypes than any infant PCV on-market and is currently being evaluated in a Phase 2 infant study. Both VAX-31 and VAX-24 are designed to improve upon the standard-of-care PCVs by covering the serotypes in circulation that are responsible for a significant portion of IPD and are associated with high case-fatality rates, antibiotic resistance and meningitis, while maintaining coverage of previously circulating strains that are currently contained through continued vaccination practice.

Vaxcyte is re-engineering the way highly complex vaccines are made through modern synthetic techniques, including advanced chemistry and the XpressCF™ cell-free protein synthesis platform, exclusively licensed from Sutro Biopharma, Inc. Unlike conventional cell-based approaches, the Company’s system for producing difficult-to-make proteins and antigens is intended to accelerate its ability to efficiently create and deliver high-fidelity vaccines with enhanced immunological benefits. Vaxcyte’s pipeline also includes VAX-A1, a prophylactic vaccine candidate designed to prevent Group A Strep infections; VAX-PG, a therapeutic vaccine candidate designed to slow or stop the progression of periodontal disease; and VAX-GI, a vaccine candidate designed to prevent Shigella. Vaxcyte is driven to eradicate or treat invasive bacterial infections, which have serious and costly health consequences when left unchecked. For more information, visitwww.vaxcyte.com.

Forward-Looking StatementsThis press release 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 VAX-24 and VAX-31, including breadth of coverage, the ability to deliver potentially best-in-class PCVs, improve upon the standard-of-care and set a new standard for immunogenicity and disease coverage; the process and timing of anticipated future development of Vaxcyte’s vaccine candidates, including the timing and availability of data for the VAX-24 and VAX-31 infant Phase 2 studies, the initiation of VAX-24 or VAX-31 infant Phase 3 studies, and the initiation of VAX-31 adult Phase 3 studies and the timing of such studies and their data readouts; the demand for Vaxcyte’s vaccine candidates; and other statements that are not historical fact. The words “anticipate,” “believe,” “could,” “expect,” “intend,” “may,” “on track,” “potential,” “should,” “would” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) convey uncertainty of future events or outcomes and are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These forward-looking statements are based on Vaxcyte’s current expectations and actual results and timing of events could differ materially from those anticipated in such forward-looking statements as a result of risks and uncertainties, including, without limitation, risks related to Vaxcyte’s product development programs, including development timelines, success and timing of chemistry, manufacturing and controls and related manufacturing activities, potential delays or inability to obtain and maintain required regulatory approvals for its vaccine candidates, and the risks and uncertainties inherent with preclinical and clinical development processes; the success, cost and timing of all development activities and clinical trials; and sufficiency of cash and other funding to support Vaxcyte’s development programs and other operating expenses. These and other risks are described more fully in Vaxcyte’s filings with the Securities and Exchange Commission (SEC), including its Quarterly Report on Form 10-Q filed with the SEC on May 7, 2025 or in other documents Vaxcyte subsequently files with or furnishes to the SEC. All forward-looking statements contained in this press release speak only as of the date on which they were made and are based on management’s assumptions and estimates as of such date, and readers should not rely upon the information in this press release as current or accurate after its publication date. Vaxcyte undertakes no duty or obligation to update any forward-looking statements contained in this release as a result of new information, future events or changes in its expectations. Readers should not rely upon the information in this press release as current or accurate after its publication date.

(1)Lower limit of the 95% confidence interval for the difference between the proportion of participants achieving the pre-defined seroconversion rate (IgG concentration ≥0.35 mcg/mL) is > -15% for each ST (https://pmc.ncbi.nlm.nih.gov/articles/PMC7360095/). Larger Phase 3 registration studies have required that lower limit of the 95% confidence interval for the difference between the proportion of participants achieving the pre-defined seroconversion rate (IgG concentration ≥0.35 mcg/mL) is > -10% for each ST.(2)Percentage of IPD caused in individuals <5 yrs of age in the U.S. in 2023 based on ABC surveillance data (https://data.cdc.gov/Public-Health-Surveillance/1998-2023-Serotype-Data-for-Invasive-Pneumococcal-/qvzb-qs6p/about_data).(3)Target point estimate of 0.6 is based on the Company’s statistical analysis of precedent Phase 2 and Phase 3 studies.