Core Insights - Vaxcyte, Inc. has received FDA clearance for the VAX-31 infant Investigational New Drug (IND) application and Breakthrough Therapy designation for adults, marking significant regulatory milestones for the company [1][6][7] - VAX-31 is a 31-valent pneumococcal conjugate vaccine (PCV) designed to prevent invasive pneumococcal disease (IPD) in both pediatric and adult populations, with coverage estimates of approximately 94% for children under five and over 95% for adults in the U.S. [2][12] - The company plans to initiate a Phase 2 study for infants by the end of January 2025 and a Phase 3 pivotal study for adults by mid-2025 [1][3][10] Regulatory Milestones - The FDA's clearance of the VAX-31 infant IND application allows for a Phase 2 study that will include a primary immunization series of three doses at two, four, and six months, followed by a booster at 12-15 months [4] - The Breakthrough Therapy designation for VAX-31 in adults is based on positive topline results from the Phase 1/2 study, which supports the advancement to a Phase 3 program [6][7] Clinical Development Plans - Vaxcyte aims to announce topline safety, tolerability, and immunogenicity data from the VAX-31 infant Phase 2 study in mid-2026, with booster dose data expected approximately nine months later [10] - The company is also advancing its VAX-24 candidate, with topline data from its Phase 2 study expected by the end of Q1 2025 [9] Disease Context - IPD remains a significant health threat, particularly in children under five, with approximately 300,000 deaths annually due to Streptococcus pneumoniae, highlighting the need for broader-spectrum vaccines like VAX-31 [5][11] - Pneumococcal disease is a leading cause of vaccine-preventable deaths in young children and is associated with high hospitalization rates in the U.S. [11][12] Company Overview - Vaxcyte is focused on developing high-fidelity vaccines to combat bacterial diseases, with VAX-31 being the broadest-spectrum PCV candidate currently in clinical trials [13] - The company utilizes advanced synthetic techniques for vaccine development, aiming to improve upon existing vaccines by covering more serotypes responsible for significant disease burden [13]

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 September 30, 2024 OR o TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 | --- | --- | |------------------------------------------------ ...

-- Company Reported Positive Topline Safety, Tolerability and Immunogenicity Data from Phase 1/2 Study of VAX-31, its 31-Valent Pneumococcal Conjugate Vaccine (PCV) Candidate, in Adults Aged 50 and Older -- -- PCV Adult Indication: VAX-31 Selected to Advance to Phase 3 Program; Initiation of Phase 3 Pivotal, Non-Inferiority Study Expected by Mid-2025 and Announcement of Topline Safety, Tolerability and Immunogenicity Data in 2026 -- -- PCV Pediatric Indication: VAX-24 Infant Phase 2 Study Topline Data from ...

MicroStockHub Vaxcyte, Inc. (NASDAQ:PCVX) is developing next-generation vaccines to prevent and treat bacterial infections through its novel Cell-Free Protein Synthesis [XpressCF] platform. PCVX's technology overcomes the limitations of conventional, cell-based vaccine approaches, delivering broad-spectrum vaccines. Its main value drivers are VAX-31 and VAX-24, which are pneumococcal conjugate vaccines that protect against invasive pneumococcal disease [IPD]. VAX-31 is in Phase 1/2 trials and is quickly pro ...

SAN CARLOS, Calif., Sept. 06, 2024 (GLOBE NEWSWIRE) -- Vaxcyte, Inc. (Nasdaq: PCVX), a clinicalstage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases, announced today the closing of its previously announced underwritten public offering of 12,087,378 shares of common stock at a public offering price of $103.00 per share and prefunded warrants to purchase 2,427,184 shares of common stock at a public offering price of $102.999 per pr ...

MicroStockHub/iStock via Getty Images Investment Overview - Background To Recent Explosive Share Price Growth Foster City, California based Vaxcyte (NASDAQ:PCVX) completed its Initial Public Offering (IPO) in June 2020, raising $287.5m via the issuance of ~18m shares priced at $16 per share. At the time, the company discussed its business as follows: Vaxcyte, formerly known as SutroVax, is a next-generation vaccine company seeking to improve global health by developing superior and novel vaccines designed t ...

Core Viewpoint - Vaxcyte, Inc. has initiated a public offering of $1.0 billion in common stock and pre-funded warrants to support its vaccine development efforts against bacterial diseases [1] Company Overview - Vaxcyte is a clinical-stage vaccine innovation company focused on engineering high-fidelity vaccines to combat bacterial diseases [5] - The company is developing broad-spectrum conjugate and novel protein vaccines, including VAX-31, a Phase 3-ready 31-valent pneumococcal conjugate vaccine, and VAX-24, a 24-valent candidate currently in Phase 2 trials [5] - Vaxcyte's pipeline also includes candidates for Group A Strep infections, periodontal disease, and Shigella prevention [6] Offering Details - The public offering includes a 30-day option for underwriters to purchase an additional $150 million in shares [1] - The offering is subject to market conditions, and there is no guarantee on its completion or terms [1] - A shelf registration statement for the securities was filed with the SEC and became effective on May 24, 2024 [3] Management and Underwriters - BofA Securities, Jefferies, Leerink Partners, Goldman Sachs & Co. LLC, Evercore ISI, Guggenheim Securities, and Mizuho are acting as joint book-running managers for the offering [2]

-- At All Doses Studied, VAX-31 Demonstrated Robust Opsonophagocytic Activity Immune Responses for All 31 Serotypes -- -- At Middle and High Doses, VAX-31 Met or Exceeded Regulatory Immunogenicity Criteria for All 31 Serotypes -- -- At All Doses Studied, VAX-31 Was Observed to be Well Tolerated and Demonstrated a Safety Profile Similar to Prevnar 20® -- -- Topline Results Further Validate Potential of Vaxcyte's Carrier-Sparing Platform to Deliver BroadestSpectrum Pneumococcal Conjugate Vaccine Candidates th ...

Core Insights - Vaxcyte, Inc. is set to present topline results from its Phase 1/2 study of VAX-31, a 31-valent pneumococcal conjugate vaccine, aimed at preventing invasive pneumococcal disease in adults aged 50 and older [1] Company Overview - Vaxcyte is focused on engineering high-fidelity vaccines to combat bacterial diseases, developing broad-spectrum conjugate and novel protein vaccines [3] - The lead candidate, VAX-24, is a Phase 3-ready 24-valent PCV, while VAX-31 is the broadest-spectrum PCV candidate currently in clinical trials [3] - Both VAX-24 and VAX-31 aim to improve upon existing PCVs by covering serotypes linked to high case-fatality rates and antibiotic resistance [3] Technology and Innovation - The company utilizes modern synthetic techniques, including advanced chemistry and the XpressCF™ cell-free protein synthesis platform, to produce complex vaccines more efficiently [4] - This innovative approach is designed to enhance the immunological benefits of the vaccines [4] Pipeline Candidates - Vaxcyte's pipeline includes several vaccine candidates: - VAX-A1 for preventing Group A Strep infections - VAX-PG for slowing or stopping periodontal disease progression - VAX-GI for preventing Shigella [4]

Core Viewpoint - Purcell & Lefkowitz LLP is investigating Vaxcyte, Inc. to determine if its directors breached fiduciary duties related to recent corporate actions [1] Group 1 - The investigation is on behalf of Vaxcyte's shareholders [1] - Shareholders interested in more information can contact the law firm for free [1] - The law firm specializes in representing shareholders affected by securities fraud and corporate misconduct [2]