Vaxcyte (PCVX) 25th Annual Needham Virtual Healthcare Conference summary

Key milestones and pipeline updates

• OPUS 1 and 2 adult Phase III studies completed enrollment; OPUS 3 still enrolling, with pivotal OPUS 1 data expected in Q4 and OPUS 2/3 data in H1 next year.

• VAX-31 infant Phase II study completed enrollment in January; full data readout expected by end of H1 next year.

• Phase I study for VAX-A1 (group A strep vaccine) planned for 2026, with future pediatric studies anticipated.

• Manufacturing and commercialization investments underway, including hiring a Chief Commercial Officer and building medical affairs.

• BLA submission for VAX-31 adult indication targeted by end of next year, aiming for potential approval in 2028.

Market dynamics and growth drivers

• Pneumococcal vaccine market currently valued at $8B, projected to grow to $12B+ in 5+ years, driven mainly by adult segment expansion.

• U.S. ACIP lowered universal vaccination age from 65 to 50, expanding eligibility by 60–65 million people.

• Market growth also fueled by potential shift to two-dose regimen and increasing adult immunization recommendations globally.

• Ex-U.S. adult market showing strong growth, with recent recommendations in Japan and Europe.

Clinical trial design and expectations

• OPUS 1 is pivotal for non-inferiority; OPUS 2 focuses on co-administration with flu vaccine; OPUS 3 targets revaccination opportunities.

• OPUS 1 compares VAX-31 to PCV20 and 21 across overlapping serotypes, aiming for non-inferiority or superiority.

• Some non-inferiority misses are expected and considered acceptable by FDA, with overall data quality prioritized.

• Phase II VAX-31 data published in Lancet ID showed strong immunogenicity, providing a benchmark for Phase III.