OPUS-1 Phase 3 Study Designed to Establish a New Standard for Adult Pneumococcal Conjugate Vaccines (PCVs) Through Head-to-Head Safety, Tolerability and Immunogenicity Comparisons of VAX-31 with Capvaxive® (PCV21) and Prevnar 20® (PCV20), the Current Standard-of-Care PCVs Topline Safety, Tolerability and Immunogenicity Data from OPUS-1 Phase 3 Study Expected in Fourth Quarter of 2026 OPUS-2 Phase 3 Study Evaluating Concomitant Administration of VAX-31 and Seasonal Influenza Vaccine Designed to Provide Real- ...

Core Insights - Vaxcyte's VAX-31 has shown promising results in a Phase 1/2 study, demonstrating robust immune responses and a safety profile comparable to Prevnar 20® [1][2][3] - The vaccine is designed to cover approximately 95% of invasive pneumococcal disease (IPD) and 88% of pneumococcal pneumonia in U.S. adults aged 50 and older, potentially offering broader coverage than current vaccines [1][8] Study Results - VAX-31 was well tolerated across all doses, with a safety profile similar to PCV20, and no serious adverse events related to the vaccine were reported [2][10] - The High Dose of VAX-31 met or exceeded non-inferiority criteria for all 20 serotypes common with PCV20 and demonstrated superior immune responses for 11 additional serotypes unique to VAX-31 [2][10] Immunogenicity Findings - VAX-31 demonstrated high geometric mean concentrations (GMCs) of immunoglobulin G (IgG) across all 31 serotypes, consistent with opsonophagocytic activity (OPA) results [10] - At the High Dose, 18 of 20 serotypes showed greater immune responses compared to PCV20, with seven achieving statistically significant higher responses [2][10] Future Development - Based on the study results, VAX-31 has advanced into a comprehensive Phase 3 adult program, with topline data expected in Q4 2026 [1][3] - The OPUS Phase 3 trials aim to support a Biologics License Application, contingent on study outcomes [3][10] About Pneumococcal Disease - Pneumococcal disease, caused by Streptococcus pneumoniae, leads to significant morbidity and mortality, particularly in older adults and young children, highlighting the need for broader-spectrum vaccines [7][8] - The CDC identifies drug-resistant strains of Streptococcus pneumoniae as a serious threat, underscoring the urgency for effective vaccination strategies [7]

Summary of Vaxcyte Conference Call Company Overview - **Company**: Vaxcyte (NasdaqGS:PCVX) - **Focus**: Development of vaccines using a cell-free protein synthesis platform, with exclusive rights in the vaccine field [3][4] Key Products and Developments VAX-31 (Pneumococcal Conjugate Vaccine) - **Current Status**: In phase 3 clinical development with a pivotal study (OPUS-1) involving 4,000 subjects, comparing VAX-31 to Pfizer's 20-valent and Merck's 21-valent vaccines [6][7] - **Expected Results**: Anticipated in Q4 2026, followed by two additional phase 3 studies (OPUS-2 and OPUS-3) in the first half of 2027 [7][18] - **Unique Selling Proposition**: VAX-31 is a 31-valent vaccine that aims to provide broader coverage and improved immune responses compared to existing vaccines [11][12] - **Phase 2 Results**: Showed better immune responses on 18 of the 20 common serotypes compared to the standard of care [11][12] VAX-A1 (Group A Strep Vaccine) - **Development Status**: Clinical development to be initiated in 2026, targeting a significant unmet need as there are currently no vaccines for Group A Strep [56][58] - **Mechanism**: Utilizes a conjugate vaccine approach with a conserved polysaccharide and proteins unique to Group A Strep [57][58] - **Market Potential**: The invasive disease burden from Group A Strep is reportedly double that of pneumococcal disease, indicating a substantial market opportunity [58] Clinical Trial Insights - **Non-Inferiority Margin**: For the phase 3 trial, a higher non-inferiority threshold of 0.67 was agreed upon, reflecting the need to demonstrate better immune responses than existing vaccines [15][16] - **Safety Studies**: OPUS-2 and OPUS-3 studies are designed to ensure a robust safety database and to evaluate immune responses in previously vaccinated individuals [18][19] Manufacturing and Regulatory Timeline - **BLA Submission**: Targeted for the end of 2027, with potential approval and launch in 2028, contingent on successful trial outcomes [33] Infant Vaccine Development (VAX-24) - **Phase 2 Results**: Mixed results with higher doses showing better immune responses; ongoing studies aim to optimize formulations for infants [36][37] - **Comparison to Prevnar**: VAX-24 demonstrated superior responses for certain serotypes compared to Prevnar 20, indicating competitive positioning [37][38] Market Context and Competitive Landscape - **Current Market**: The pneumococcal vaccine market is significant, with Vaxcyte aiming to capture a larger share through innovative vaccine technology [58] - **Regulatory Environment**: Historical precedents show that vaccines can achieve approval even with some missed serotypes, provided they demonstrate overall robust immune responses [46][47] Conclusion - Vaxcyte is positioned to potentially lead in the pneumococcal vaccine market with VAX-31 and is exploring a significant opportunity in the Group A Strep vaccine space with VAX-A1. The company is focused on advancing its clinical trials and ensuring regulatory compliance to achieve market entry.

Summary of Vaxcyte Conference Call Company Overview - **Company**: Vaxcyte - **Event**: TD Cowen's 46th Annual Healthcare Conference - **Key Participants**: Grant Pickering (Co-Founder and CEO), Andrew Guggenhime (President and CFO), Jim Wassil (EVP and COO) [1][2] Core Highlights - **VAX-31 Development**: Vaxcyte is in phase 3 clinical development for its lead vaccine, VAX-31, with three ongoing studies aimed at a Biologics License Application (BLA) filing anticipated by the end of next year [2][3] - **OPUS-1 Study**: A pivotal study comparing VAX-31 to existing 20-valent and 21-valent vaccines, with results expected in Q4 of this year [2][3] - **Infant Study**: An ongoing infant study for VAX-31 will also report results in the first half of next year [3] Technology and Competitive Advantage - **Innovative Conjugation Technology**: Vaxcyte's technology allows for site-specific conjugation of polysaccharides to protein carriers, improving immunogenicity compared to traditional methods that lead to reduced immune responses as valency increases [5][6][8] - **Higher Valency**: Vaxcyte claims to achieve a higher valency (31) than competitors (20 or 21), which is expected to enhance coverage and immune response [8][10] Clinical Study Insights - **Non-Inferiority Expectations**: The company is confident in achieving non-inferior immune responses against the standard of care vaccines, with 10 or 11 additional serotypes in VAX-31 [9][10] - **Serotype Performance**: There is acknowledgment that missing on a few serotypes is acceptable, as long as the overall data supports the vaccine's efficacy [19][30] Market Dynamics - **Adult Vaccination Growth**: The adult pneumococcal vaccine market is expanding, with recent changes allowing vaccination for adults starting at age 50, adding approximately 60 million eligible adults in the U.S. [43] - **Global Trends**: Developed countries in Europe and Asia are also adopting universal vaccination recommendations for adults, contributing to market growth [44] Future Studies - **OPUS-2 and OPUS-3**: These studies will explore the combination of VAX-31 with flu vaccination and revaccination strategies for adults who have previously received pneumococcal vaccines [39][40] Regulatory Considerations - **FDA Engagement**: Vaxcyte has maintained constructive dialogue with the FDA regarding trial designs and is optimistic about the data supporting their vaccine [33][35] - **ACIP Recommendations**: The company aims for a preferred recommendation from ACIP, which would enhance market positioning [36][37] Underappreciated Aspects - **Group A Strep Vaccine Potential**: Vaxcyte is also developing a conjugate vaccine for Group A Strep, which presents significant public health opportunities due to rising rates of invasive disease [55] Conclusion Vaxcyte is positioned to make significant advancements in the pneumococcal vaccine market with its innovative technology and upcoming clinical data. The company is also exploring new opportunities in Group A Strep, which could further enhance its portfolio and impact on public health [56][57]

Vaxcyte (PCVX) is a clinical-stage vaccine innovation company focused on developing next-generation vaccines to protect people from serious bacterial infectious diseases. While Vaxcyte is still a clinical-stage company, Wall Street seems highly optimistic about PCVX stock, rating it as a consensus “Strong Buy” and forecasting potential upside of 76% from current levels based on the average price target of $109. Vaxcyte is even attracting long-term growth investors' interest. This small-cap biotech is up ...

Vaxcyte (NasdaqGS:PCVX) Q4 2025 Earnings call February 24, 2026 04:30 PM ET Company ParticipantsAndrew Guggenhime - President and CFOAsad Haider - Managing DirectorDina Ramadane - Biotech Equity Research AssociateEvan Wang - VP of Equity ResearchGrant Pickering - CEOJim Wassil - EVP and COOJonathan Miller - Managing Director of Biotech and Pharma Equity ResearchMike Miletich - Chief Commercial OfficerConference Call ParticipantsCarter Gould - Managing Director and Senior AnalystJoseph Stringer - Senior Anal ...

Financial Data and Key Metrics Changes - As of December 31, 2025, the company reported $2.4 billion in cash equivalents and investments, with a subsequent public equity offering raising approximately $600.2 million in net proceeds, enhancing financial flexibility [19][20] - Total expenses increased in 2025 compared to the prior year, driven by investments in commercial manufacturing readiness and clinical program advancements [20] - The company expects total expenses, particularly in R&D, to increase significantly in 2026 relative to both full year 2025 and fourth quarter 2025 annualized levels [21] Business Line Data and Key Metrics Changes - The Pneumococcal Conjugate Vaccine (PCV) franchise is seeing accelerating growth, particularly in the adult market, driven by expanded age group recommendations in the U.S. and increasing international adoption [4][5] - The OPUS Phase 3 program for VAX-31 is underway, with expectations to set a new standard for adult pneumococcal vaccines [5][10] - The company modified the ongoing VAX-31 infant phase 2 study to include an optimized dose arm based on learnings from the VAX-24 study, with enrollment now complete [7][16] Market Data and Key Metrics Changes - The adult PCV market is experiencing growth due to expanded vaccination recommendations, highlighting a clear public health need for broader spectrum protection [4][5] - The company anticipates significant commercial potential from the OPUS-3 study, which targets adults previously vaccinated with lower valency vaccines, creating a large catch-up population [80] Company Strategy and Development Direction - The company is focused on advancing its clinical programs and establishing the necessary infrastructure for commercialization, particularly for the PCV franchise [9][23] - A long-term investment of up to $1 billion in U.S. manufacturing and services is underway to support global commercial demand for PCV candidates [8] - The company plans to resume development of its Group A Strep vaccine candidate, VAX-A1, with a Phase 1 study expected to initiate this year [17][56] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the upcoming clinical readouts and the potential to improve public health through the PCV franchise [5][23] - The company believes it is well-positioned to advance its programs through multiple upcoming data readouts while continuing to invest in commercialization capabilities [8][19] - Management highlighted the importance of engaging with policymakers and public health stakeholders to support science-based vaccine policy and manufacturing readiness [22] Other Important Information - The company has completed the construction of a dedicated large-scale manufacturing facility on time and on budget, designed to support global demand for its PCV candidates [7][8] - The OPUS-1 trial is designed to establish a best-in-class profile for VAX-31, with a focus on safety, tolerability, and immunogenicity [10][12] Q&A Session Summary Question: How is the study power for OPUS-1 to show statistical non-inferiority against each comparator? - Management confirmed that the pivotal Phase 3 study was locked down in consultation with the FDA, and they have high confidence in their ability to demonstrate non-inferiority against Prevnar 20 [26][27] Question: What is remaining to be discussed regarding the manufacturing consistency study? - Management indicated that discussions with the FDA are constructive, and they anticipate the manufacturing consistency study will commence in conjunction with the expected BLA timing [30][31] Question: What do you need to show for a catch-up recommendation in the adult market? - Management stated that they need to demonstrate improved responses to serotypes previously vaccinated against and robust immunogenicity for incremental serotypes [38][39] Question: What factors are considered in announcing infant data either sequentially or together? - Management will weigh the pros and cons of each approach, focusing on the strategic importance of the data [84]

Financial Data and Key Metrics Changes - As of December 31, 2025, the company reported $2.4 billion in cash equivalents and investments, with a subsequent public equity offering raising approximately $600.2 million in net proceeds, enhancing financial flexibility [18][19] - Total expenses increased in 2025 compared to the prior year, driven by investments in commercial manufacturing readiness and clinical program advancements [19][20] - The company expects total expenses, particularly in R&D, to increase significantly in 2026 due to higher manufacturing and clinical trial costs [20][21] Business Line Data and Key Metrics Changes - The Pneumococcal Conjugate Vaccine (PCV) franchise is seeing accelerating growth, particularly in the adult market, driven by expanded age group recommendations and international adoption [3][4] - The OPUS Phase 3 program for VAX-31 is designed to support a planned Biologics License Application (BLA) submission, with pivotal trials underway to establish a best-in-class profile [9][10] Market Data and Key Metrics Changes - The adult PCV market is experiencing growth due to increased vaccination recommendations and the need for broader serotype coverage [4][5] - The company is positioned to capture a significant market opportunity with VAX-31, which aims to cover over 90% of invasive pneumococcal disease and acute otitis media in infants [15] Company Strategy and Development Direction - The company is focused on advancing its clinical programs and establishing the necessary infrastructure for commercialization, particularly for the PCV franchise [8][23] - A long-term investment of up to $1 billion in U.S. manufacturing and services is underway to support global demand for PCV candidates [7] - The company plans to resume development of its Group A Streptococcus vaccine candidate, VAX-A1, with a Phase 1 study expected to start this year [16][54] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the upcoming clinical readouts and the potential for VAX-31 to set a new standard in adult pneumococcal vaccination [4][23] - The company believes it is well-positioned for a catalyst-rich period ahead, with multiple data readouts expected in the next 12-18 months [23] Other Important Information - The company has completed the construction of a dedicated large-scale manufacturing facility on time and on budget, designed to support global commercial demand [6][7] - Engagement with policymakers and public health stakeholders has been formalized to emphasize the importance of science-based vaccine policy and manufacturing readiness [22] Q&A Session Summary Question: How is the study power for OPUS-1 to show statistical non-inferiority against each comparator? - The study was designed in consultation with the FDA, and the company has high confidence in its ability to demonstrate non-inferiority based on previous head-to-head studies [25][26] Question: What is remaining to be discussed regarding the manufacturing consistency study? - Conversations with the FDA are constructive, and the key agreement reached last summer allows for advancement into Phase 3, with the manufacturing study expected to align with BLA timing [29][30] Question: What do you need to show for a catch-up recommendation in the adult market? - The company aims to demonstrate improved responses to serotypes previously vaccinated against and robust immunogenicity for incremental serotypes [34][36] Question: What drives confidence in the new dosing regimen for the infant study? - The company has high confidence based on previous data showing dose responsiveness and aims to enhance immune responses for key serotypes [38][40] Question: What are the plans for the Group A Streptococcus vaccine development? - The company plans to start with a safety assessment in adults and will look at immunogenicity, with a focus on moving into toddlers for proof of concept [44][46] Question: How will the OPUS-2 and OPUS-3 studies impact ACIP recommendations? - OPUS-3 is seen as strategically important for potential catch-up recommendations, while OPUS-2 will help round out the safety database [75][78]

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 ______________________________________________________________ FORM 10-K ______________________________________________________________ (Mark One) x ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2025 OR o TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _________ to ______ ...

Exhibit 99.1 Vaxcyte Reports Fourth Quarter and Full Year 2025 Financial Results and Provides Business Update Comprehensive VAX-31 Adult Phase 3 Clinical Program, Finalized in Consultation and Alignment with FDA, Advances with Three Phase 3 Studies Underway to Support Planned BLA Submission Topline Safety, Tolerability and Immunogenicity Data from OPUS-1 Expected in Fourth Quarter of 2026; OPUS-2 and OPUS-3 Results Expected in First Half of 2027 Enrollment Completed in VAX-31 Infant Phase 2 Dose-Finding Stu ...