Vaxcyte (PCVX) investor relations material

Company vision and technology

• Focus on leveraging cell-free protein synthesis for novel and improved vaccines, enabling production of proteins not possible with conventional methods.

• Site-specific conjugation technology underpins the pneumococcal conjugate vaccine franchise and enables broader spectrum vaccines.

• Carrier-sparing conjugates allow for broader coverage and improved immune responses by optimizing protein carrier amounts.

• Technology is also being applied to develop a first-in-class Group A Strep vaccine entering clinical trials this year.

Clinical development and trial updates

• VAX-31, a 31-valent pneumococcal conjugate vaccine, is the primary focus, with pivotal phase III OPUS-1 results expected in Q4 this year.

• Two additional phase III studies (OPUS-2 and OPUS-3) will read out in the first half of next year, supporting a BLA filing by end of next year.

• OPUS-2 evaluates VAX-31 with flu vaccine; OPUS-3 assesses immune response in subjects previously vaccinated with lesser valent PCVs.

• Manufacturing consistency study is being finalized and will be included in the BLA submission.

Clinical results and regulatory considerations

• VAX-31 phase II data showed superior immune responses on 18 of 20 common serotypes compared to the 20-valent standard, with expanded coverage.

• Non-inferiority margin for phase III in adults was set higher (0.67 vs. 0.5) to address regulatory concerns about immune response levels.

• Regulators allow some misses on serotypes if overall coverage and antibody titers remain high, supporting a best-in-class profile.