Summary of Vaxcyte (PCVX) Conference Call Company Overview - Vaxcyte is a clinical-stage biotechnology company focused on developing next-generation pneumococcal vaccines, particularly the PPD franchise [2][3][4] Core Points and Arguments Development Programs - The company is preparing to initiate a Phase III program for its adult pneumococcal vaccine, with positive data recently unveiled for the infant indication [4][8] - The Phase III program is expected to start by mid-2025, with a non-inferiority study reading out in 2026 and additional studies concluding by 2027 [8][9] Regulatory Environment - Vaxcyte is operating under a breakthrough therapy designation, allowing for more frequent discussions with the FDA [16][17] - The company does not anticipate the need for placebo-controlled trials for its vaccines, given established safety and efficacy [14][15] Competitive Landscape - Vaxcyte's 31-valent vaccine is positioned to be competitive in the market, with a focus on demonstrating expanded coverage for adults previously vaccinated with other pneumococcal vaccines [11][12][27] - The company believes that having the broadest serotype coverage (95% disease coverage) will provide a competitive advantage [27][30] Financial Position - As of March 31, Vaxcyte reported approximately $3 billion on its balance sheet, which is expected to support key milestones through 2027 [59][61] - The company is evaluating its investment priorities to further strengthen its financial position [61] Manufacturing Readiness - Vaxcyte plans to launch its adult vaccine from existing facilities and is building a new dedicated facility with Lonza, expected to be completed early next year [62][63] Important but Overlooked Content - The company is closely monitoring the macro environment, including potential policy changes in Washington, but asserts that these have not impacted its fundamental mission [5][6] - Vaxcyte is exploring higher doses in its ongoing studies to optimize the immune response for its vaccines [44][45] - The company is addressing enrollment dynamics for its trials, noting a slight decrease in infant enrollment but compensating by increasing the number of sites [57][58] This summary encapsulates the key points discussed during the Vaxcyte conference call, highlighting the company's strategic direction, competitive positioning, and financial health.

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 ___________________________________________________ FORM 10-Q ___________________________________________________ (Mark One) x QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 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 ____________ Commissi ...

Exhibit 99.1 Vaxcyte Reports First Quarter 2025 Financial Results and Provides Business Update -- Company Reported Positive Topline Safety, Tolerability and Immunogenicity Data from Phase 2 Dose-Finding Study of VAX-24 in Healthy Infants; Balance of Data Expected by End of 2025 -- -- Initiated Second and Final Stage of VAX-31 Infant Phase 2 Dose-Finding Study; Topline Safety, Tolerability and Immunogenicity Data from Primary Three-Dose Immunization Series Expected in Mid-2026, With Complete Booster Data Up ...

-- Company Reported Positive Topline Safety, Tolerability and Immunogenicity Data from Phase 2 Dose- Finding Study of VAX-24 in Healthy Infants; Balance of Data Expected by End of 2025 -- -- Initiated Second and Final Stage of VAX-31 Infant Phase 2 Dose-Finding Study; Topline Safety, Tolerability and Immunogenicity Data from Primary Three-Dose Immunization Series Expected in Mid- 2026, With Complete Booster Data Up to Nine Months Later -- -- Company Expects to Initiate VAX-31 Adult Phase 3 Pivotal, Non-Infe ...

SAN CARLOS, Calif., May 01, 2025 (GLOBE NEWSWIRE) -- Vaxcyte, Inc. (Nasdaq: PCVX), a vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases, today announced it has appointed Dr. Olivier Brandicourt, a veteran biopharmaceutical industry executive and the former Chief Executive Officer of Sanofi S.A., to its Board of Directors. “We are thrilled to welcome Olivier to Vaxcyte’s Board of Directors,” said Grant Pickering, Chief Executive Offi ...

Vaxcyte (PCVX) is a clinical-stage biotech focused on developing vaccines to prevent or treat bacterial infectious diseases.In the past month, PCVX's shares have nosedived 56%. This downside came after Vaxcyte reported mixed results from a phase II study on its investigational pneumococcal conjugate vaccine (PCV) in healthy infants.Adding to this headwind, the broader biotech/drug sector is feeling the pressure from the resignation of a senior FDA official instrumental in driving biotech innovation, which h ...

Analyst's Disclosure: I/we have no stock, option or similar derivative position in any of the companies mentioned, and no plans to initiate any such positions within the next 72 hours. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article. This article is published by Terry Chrisomalis, who runs the Biotech Analysis Central pharmaceutical ...

-- At All Doses Evaluated, VAX-24 Was Well-Tolerated and Demonstrated a Safety and Tolerability Profile Similar to Prevnar 20® (PCV20) -- -- At All Doses Evaluated, VAX-24 Elicited Substantial Immune Responses Following Primary Three- Dose Immunization Series; Topline Results Also Include Interim Booster Dose IgG Data Showing Robust Memory Responses Across All Doses -- -- Dose-Dependent Immune Responses Consistently Demonstrated and Little to No Evidence of Carrier Suppression Was Observed, Supporting Platf ...

Vaxcyte, Inc. (NASDAQ:PCVX) Q4 2024 Earnings Conference Call February 25, 2025 4:30 PM ET Company Participants Andrew Guggenhime - President and CFO Grant Pickering - CEO Jim Wassil - EVP and COO Conference Call Participants Roger Song - Jefferies Salim Syed - Mizuho Umer Raffat - Evercore Seamus Fernandez - Guggenheim Tom Shrader - BTIG Joseph Stringer - Needham & Company Operator Good afternoon, my name is Jess, and I will be your conference operator today. At this time, I would like to welcome everyone t ...

Corporate Presentation February 25, 2025 Highlights: Potential Best-in-Class Pneumococcal Conjugate Vaccine (PCV) Franchise Positive Phase 1/2 Adult Data for VAX-31 and VAX-24 Validate Potential of Site-Specific, Carrier-Sparing Platform POTENTIAL BEST-IN-CLASS PCV FRANCHISE HIGHLY ATTRACTIVE PCV MARKET Forward-Looking Statements This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, ...