Strong Financial Position and Recent Financing
Cash, cash equivalents and investments of $2.4 billion as of Dec 31, 2025, plus a subsequent public equity offering raising approximately $600.2 million in net proceeds; company states cash runway to at least the end of 2028.
Late-Stage Clinical Momentum — OPUS Phase III Program Initiated
Initiated OPUS-1 (pivotal noninferiority) in December, OPUS-2 (concomitant with seasonal influenza vaccine) in January, and OPUS-3 this month; the three OPUS trials will enroll ~6,000 adults total with ~3,400 receiving VAX-31; top-line OPUS-1 safety/tolerability/immunogenicity data expected in Q4 2026, OPUS-2/3 readouts expected in H1 2027.
Positive Phase II Immunogenicity Signals in Adults
Company cites 'unprecedented' Phase II adult results for VAX-31 versus Prevnar 20: directionally higher responses across common serotypes (18 of 20 directionally higher in Phase II) with 7 of 20 statistically significantly higher in Phase II, and 10–11 incremental serotypes over comparators.
Infant Program Enrollment Complete and Broad Pediatric Coverage
VAX-31 infant Phase II modified to include an optimized higher-dose arm; enrollment complete with 900 infants dosed. Company claims VAX-31 is designed to cover over 90% of invasive pneumococcal disease (IPD) and acute otitis media in U.S. children and states coverage of ~95%–98% of circulating disease in the U.S. and Europe, respectively.
Manufacturing and Commercial Readiness Achievements
Completed construction of a dedicated large-scale manufacturing facility on time and on budget; initiated build-out of a high-volume custom fill-finish production line in North Carolina as part of up to $1 billion long-term U.S. manufacturing and services investment; began scaling commercial organization including hiring first Chief Commercial Officer and launching launch planning activities.
Pipeline Re‑acceleration — VAX-A1 (Group A Strep) Resumed
After a prior pause, company plans to initiate a Phase I adult trial of VAX-A1 in 2026 focused on safety, tolerability and immunogenicity (serum and saliva IgG/IgA); program targeting Australia for early proof-of-concept given local disease burden.
Regulatory Engagement and Program Design Aligned with FDA
Pivotal Phase III program and supporting studies were designed in consultation with the FDA; company notes FDA feedback allowing limited serotype misses in totality-based licensure assessments and alignment around post-marketing surveillance approaches consistent with prior PCV approvals.