Vaxcyte Q1 2024 Financial Results and Business Update

Vaxcyte, Inc., a clinical-stage vaccine innovation company, announced its financial results for the first quarter ending March 31, 2024, and provided a significant business update. The company has made notable progress in its pneumococcal conjugate vaccine (PCV) programs, specifically with its vaccine candidates VAX-24 and VAX-31, which aim to offer the broadest coverage against invasive pneumococcal disease (IPD).

The company has completed enrollment for its VAX-31 adult Phase 1/2 study and expects to release topline safety, tolerability, and immunogenicity data by the third quarter of 2024. Following this, Vaxcyte plans to advance either VAX-24 or VAX-31 into a Phase 3 clinical development program for adults. Additionally, the VAX-24 infant Phase 2 study has also completed enrollment, with initial data from the primary immunization series anticipated by the end of the first quarter of 2025, followed by booster dose data by the end of 2025.

Financially, Vaxcyte ended the first quarter with $1.9 billion in cash, cash equivalents, and investments, boosted by net proceeds of $816.5 million from a public offering in February 2024. This strong financial position supports the advancement of its PCV franchise and the expansion of its manufacturing infrastructure.

Key highlights from the first quarter include:
1. PCV Franchise Adult Indication: Enrollment for the Phase 1/2 study of VAX-31, a 31-valent PCV candidate, was completed in January 2024. This study evaluates the vaccine's safety, tolerability, and immunogenicity at three dose levels in comparison to Prevnar 20® in adults aged 50 and older.

2. PCV Franchise Infant Indication: Enrollment for the VAX-24 Phase 2 study was completed in March 2024. This study, which includes 802 healthy infants, is assessing the safety, tolerability, and immunogenicity of VAX-24 at three dose levels and in comparison to VAXNEUVANCE™ and PCV20.

3. Equity Financing: Vaxcyte successfully completed a public offering in February 2024, raising $862.5 million, before expenses, which strengthened its financial position and supports its ongoing and future projects.

Looking ahead, Vaxcyte anticipates several key milestones:
- For the adult indication, the company expects to announce data from the VAX-31 Phase 1/2 study in the third quarter of 2024 and to advance either VAX-24 or VAX-31 into Phase 3 trials.
- For the infant indication, initial data from the VAX-24 Phase 2 study's primary immunization series is expected by the first quarter of 2025, with booster dose data to follow by the end of 2025.

In terms of financial performance, Vaxcyte reported an increase in research and development expenses to $94.6 million for the first quarter of 2024, up from $58.1 million in the same period in 2023. This rise is attributed to the ongoing clinical studies and manufacturing expenses related to the planned Phase 3 clinical trials for its PCV candidates. General and administrative expenses also increased to $19.9 million from $13.1 million, primarily due to the growth in personnel.

The net loss for the first quarter of 2024 was $95.0 million, compared to $60.5 million in the same period in 2023. The company's cash and investments stood at $1.9 billion as of March 31, 2024, up from $1.2 billion at the end of 2023. 

Vaxcyte continues to innovate in vaccine development using modern synthetic techniques and its XpressCF™ cell-free protein synthesis platform, aiming to produce high-fidelity vaccines efficiently. Their pipeline includes not only PCV candidates but also vaccines for Group A Strep infections, periodontal disease, and Shigella.

Vaxcyte is committed to developing vaccines that address significant public health needs, leveraging its financial and technological resources to advance its clinical programs and prepare for potential global commercialization.

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