Clinical TrialMay 6, 2026, 04:07 PM
Vaxcyte Completes Enrollment for VAX-31 Phase 3 & Infant Phase 2 Trials
AI Summary
Vaxcyte, Inc. announced the completion of enrollment for its VAX-31 adult Phase 3 trials (OPUS-1, OPUS-2, OPUS-3) and the VAX-31 infant Phase 2 dose-finding study. Topline data for OPUS-1 is expected in Q4 2026, with OPUS-2 and OPUS-3 results in H1 2027. The company reported a strong cash position of $2.74 billion as of March 31, 2026, including $601.8 million in net proceeds from a February 2026 equity offering, and plans to initiate a Phase 1 study for VAX-A1 in mid-2026. Q1 2026 net loss widened to $320.6 million due to increased R&D expenses supporting clinical and manufacturing advancements.
Key Highlights
- Enrollment completed for VAX-31 adult Phase 3 trials (OPUS-1, OPUS-2, OPUS-3) with 6,191 adults dosed.
- Topline data from OPUS-1 Phase 3 trial expected in Q4 2026.
- Results from OPUS-2 and OPUS-3 Phase 3 trials expected in H1 2027.
- Enrollment completed for VAX-31 infant Phase 2 study with 900 infants dosed; data expected by H1 2027.
- Initiate Phase 1 adult clinical study for VAX-A1 in mid-2026.
- Cash, cash equivalents, and investments totaled $2.74 billion as of March 31, 2026.
- Net proceeds of $601.8 million from February 2026 equity offering.
- Q1 2026 R&D expenses increased to $312.8 million from $148.1 million in Q1 2025.
- Q1 2026 net loss was $320.6 million, compared to $140.7 million in Q1 2025.