Vaxcyte, Inc. (PCVX), a clinical-stage vaccine innovation company, reported its fourth-quarter and full-year 2025 financial results and provided a business update.
The company's lead program is VAX-31, a 31-valent pneumococcal conjugate vaccine (PCV) candidate currently in a Phase 3 adult clinical program and a Phase 2 infant study. VAX-31 is designed to provide the broadest serotype coverage of any PCV in clinical development, aiming to prevent invasive pneumococcal disease (IPD) and pneumonia. The FDA has granted Breakthrough Therapy Designation for VAX-31 in adults.
In adults, three pivotal Phase 3 trials (OPUS-1, OPUS-2, and OPUS-3) are underway, enrolling thousands of participants to evaluate safety, tolerability, and immunogenicity compared to current standards of care, Prevnar 20 and Capvaxine. Topline data from OPUS-1 is expected in the fourth quarter of 2026, while readouts from OPUS-2 and OPUS-3 are anticipated in the first half of 2027.
In infants, enrolment has been completed in a Phase 2 dose-finding study, with topline data expected in the first half of 2027.
Beyond VAX-31, Vaxcyte is advancing:
•VAX-24, a 24-valent PCV candidate for infants, currently in Phase 2 clinical development, designed to cover more serotypes than any marketed infant PCV.
•VAX-XL, a third-generation PCV in early development, leveraging carrier-sparing conjugation technology to further expand coverage.
•VAX-A1, a novel vaccine candidate for Group A Strep, with a Phase 1 adult study planned for 2026.
•VAX-GI, a preclinical vaccine candidate targeting Shigella infections.
The company ended December 31, 2025, with cash, cash equivalents and investments of $2.4 billion.
For Q4 2025, net loss was $246.5 million, compared to $137.1 million in the year ago quarter. For the full year net loss widened to $766.6 million compared to $463.9 million from the prior year.
In Q4 2025, Vaxcyte incurred an additional $21.8 million in capital and facility buildout expenditures related to the construction of its dedicated Lonza manufacturing facility. By year-end, total expenditures reached $335.4 million, with the buildout completed in Q1 2026 within the original projected budget of up to $350 million. This facility is intended to support the potential global commercialization of the company's PCV program.
PCVX has traded between $27.66 and $83.33 over the past year. The stock closed Tuesday's session at $61.35, up 1.81%. In overnight trading Wednesday, the stock is down 2.97% at $59.53.
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