Vaxcyte Q2 2024 Financial Results and Business Update

Vaxcyte, Inc., a clinical-stage innovator in vaccine engineering, has disclosed its financial performance for the second quarter ending June 30, 2024, alongside updates on its ongoing projects. The company, focused on developing high-fidelity vaccines to combat bacterial diseases, revealed progress in their pneumococcal conjugate vaccine (PCV) programs and other notable ventures.

CEO and Co-founder Grant Pickering highlighted that the VAX-31 adult Phase 1/2 study's topline safety, tolerability, and immunogenicity data is anticipated in September 2024. This study is expected to shed light on the vaccine’s potential across the adult demographic. Post-results, Vaxcyte plans to advance either VAX-24 or VAX-31 into Phase 3 clinical development for adults. VAX-24’s infant Phase 2 study data from the primary immunization series is expected by the first quarter of 2025, with booster dose data by the end of 2025. VAX-24 is designed to cover more serotypes than any current infant pneumococcal vaccine.

Key achievements in the second quarter include the publication of VAX-24 Phase 2 data for adults aged 65 and older in the journal Vaccine. This study compared VAX-24’s 24-valent, carrier-sparing PCV with Prevnar 20® (PCV20), focusing on safety, tolerability, and immunogenicity for preventing invasive pneumococcal disease (IPD). Results showed VAX-24 had a comparable safety profile to PCV20 and demonstrated improved immune responses.

Additionally, the National Institute of Allergy and Infectious Diseases (NIAID) awarded a $9.5 million grant for a preclinical Chlamydia vaccine development program. This project, in collaboration with the University of North Carolina at Chapel Hill and the University of Chicago, addresses the need for a vaccine against Chlamydia, a prevalent bacterial STI that can lead to severe reproductive health complications.

In governance, Vaxcyte welcomed John Furey to its Board of Directors. Furey, a biopharmaceutical veteran with over three decades of experience, brings extensive knowledge from his tenure at Baxter and Pfizer, where he held significant roles in vaccine business units globally. He currently serves as CEO of Imvax, a biotechnology company focused on cancer immunotherapies.

Financially, as of June 30, 2024, Vaxcyte reported $1.9 billion in cash, cash equivalents, and investments, up from $1.24 billion at the end of 2023. The company’s R&D expenses for the quarter were $131.5 million, a substantial increase from $72.7 million the previous year, attributed mainly to higher manufacturing costs for PCV programs and ongoing clinical trials. General and administrative expenses also rose to $21.5 million, compared to $14.5 million in the same period in 2023, driven by increased personnel costs.

Vaxcyte recorded a net loss of $128.7 million for the quarter, compared to $68.3 million in the corresponding period of 2023. This loss reflects the heightened investment in R&D and administrative activities. The company continues to invest in constructing a dedicated manufacturing suite at Lonza, incurring $38.2 million in capital and facility expenditures in the second quarter of 2024, bringing the total to $140 million as of June 30, 2024.

Looking ahead, Vaxcyte is poised to announce several key milestones, including the VAX-31 adult Phase 1/2 study results in September 2024, and potentially advancing either VAX-24 or VAX-31 to Phase 3 trials. For the infant PCV program, topline data from the VAX-24 primary immunization series is expected by Q1 2025, with booster dose data by the end of 2025.

Vaxcyte is committed to leveraging advanced synthetic techniques and the XpressCF™ cell-free protein synthesis platform to accelerate vaccine development. Their pipeline includes VAX-A1 for Group A Strep, VAX-PG for periodontal disease, and VAX-GI for Shigella, all aimed at addressing significant public health needs.