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Mar 31
Vaxcyte Q1 2025 Earnings Report
Vaxcyte reported financial results for the first quarter ended March 31, 2025, and provided a business update.
Key Takeaways
Vaxcyte reported a net loss of $140.7 million for the first quarter of 2025, an increase from the $95.0 million net loss in the same period last year, primarily due to increased R&D and G&A expenses. The company ended the quarter with approximately $3.0 billion in cash, cash equivalents, and investments.
Reported positive topline safety, tolerability, and immunogenicity data from the Phase 2 dose-finding study of VAX-24 in healthy infants.
Initiated the second and final stage of the VAX-31 infant Phase 2 dose-finding study.
Expects to initiate the VAX-31 adult Phase 3 pivotal study by mid-2025.
Announced VAX-XL, a third-generation pneumococcal conjugate vaccine candidate.
Appointed Dr. Olivier Brandicourt to the Board of Directors.
Vaxcyte
Vaxcyte
Forward Guidance
Vaxcyte anticipates several key milestones in the clinical development of its PCV programs, including initiating Phase 3 studies for VAX-31 in adults and infants and announcing further data from the VAX-24 and VAX-31 infant Phase 2 studies.
Positive Outlook
- Initiate VAX-31 adult Phase 3 pivotal study by mid-2025.
- Announce topline safety, tolerability, and immunogenicity data for VAX-31 adult Phase 3 in 2026.
- Initiate remaining VAX-31 adult Phase 3 studies in 2025 and 2026.
- Announce data from remaining VAX-31 adult Phase 3 studies in 2026 and 2027.
- Announce the balance of VAX-24 Phase 2 infant data by end of 2025.
Challenges Ahead
- Timeline for initiating VAX-24 or VAX-31 infant Phase 3 program is pending VAX-31 infant Phase 2 readout.
- Complete booster data for VAX-31 infant Phase 2 is expected up to nine months after the primary series data in mid-2026.
- Clinical trial outcomes are subject to risks and uncertainties.
- Potential delays in obtaining and maintaining required regulatory approvals.
- Sufficiency of cash and funding is subject to risks.