Vaxcyte(PCVX)

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Vaxcyte Reports Fourth Quarter and Full Year 2024 Financial Results and Provides Business Update
Newsfilter· 2025-02-25 21:01
Core Insights - Vaxcyte, Inc. has made significant progress in its clinical programs for broad-spectrum pneumococcal conjugate vaccines (PCVs), with plans to initiate a Phase 3 study for VAX-31 by mid-2025 and to announce topline data in 2026 [1][3][15] - The company raised approximately $2.2 billion in net proceeds from two follow-on equity offerings in 2024, strengthening its financial position with $3.1 billion in cash and equivalents as of December 31, 2024 [2][20] - Vaxcyte's VAX-31 and VAX-24 candidates have shown promising results in clinical trials, with VAX-31 receiving Breakthrough Therapy designation from the FDA for the prevention of invasive pneumococcal disease (IPD) in adults [9][18] Clinical Development - Vaxcyte is on track to announce topline safety, tolerability, and immunogenicity data from the VAX-24 infant Phase 2 study by the end of Q1 2025, followed by booster dose data by the end of 2025 [1][11] - The VAX-31 infant Phase 2 study has progressed to its final stage, with topline data expected in mid-2026 [1][12] - Positive topline results from the Phase 1/2 study of VAX-31 in adults aged 50 and older were reported, demonstrating a safety profile similar to Prevnar 20 and robust immune responses [4][5] Financial Performance - For the year ended December 31, 2024, Vaxcyte reported a net loss of $463.9 million, compared to a net loss of $402.3 million in 2023 [20][25] - Research and development expenses increased to $476.6 million in 2024 from $332.3 million in 2023, primarily due to heightened development activities for adult and infant PCV programs [20][25] - The company incurred $127.8 million in capital and facility buildout expenditures related to the construction of a dedicated manufacturing suite to support potential global commercialization [20][25] Leadership and Strategic Initiatives - Vaxcyte has strengthened its leadership team with key appointments, including Harp Dhaliwal as Chief Technical Operations Officer and Roger Nosal as Head of Global Regulatory and Quality Assurance [14][10] - The company is investing in its early-stage pipeline, targeting antibiotic-resistant pathogens such as Group A Strep and Shigella, alongside its PCV candidates [3][18]
Vaxcyte to Report Fourth Quarter and Full Year 2024 Financial Results on February 25, 2025
Globenewswire· 2025-02-12 21:05
Core Insights - Vaxcyte, Inc. will report its financial results for Q4 and full year 2024 on February 25, 2025, followed by a conference call and webcast to discuss the results and provide a business update [1] Company Overview - Vaxcyte is a clinical-stage vaccine innovation company focused on engineering high-fidelity vaccines to combat bacterial diseases [3] - The company is developing broad-spectrum conjugate and novel protein vaccines, including VAX-31, a 31-valent pneumococcal conjugate vaccine candidate, and VAX-24, a 24-valent PCV candidate [3] - VAX-31 is advancing to a Phase 3 adult clinical program and is currently in a Phase 2 infant clinical program, aimed at preventing invasive pneumococcal disease in both adults and infants [3] - VAX-24 is designed to cover more serotypes than any infant PCV currently on the market and is also in a Phase 2 infant study [3] Technology and Innovation - Vaxcyte utilizes modern synthetic techniques, including advanced chemistry and the XpressCF™ cell-free protein synthesis platform, to produce complex vaccines [4] - The company's approach aims to accelerate the creation and delivery of high-fidelity vaccines with enhanced immunological benefits [4] Additional Pipeline Candidates - Vaxcyte's pipeline includes VAX-A1, a prophylactic vaccine for Group A Strep infections; VAX-PG, a therapeutic vaccine for periodontal disease; and VAX-GI, a vaccine candidate for Shigella [4]
Vaxcyte Advances to Second Stage of Ongoing Phase 2 Study Evaluating VAX-31 for the Prevention of Invasive Pneumococcal Disease in Infants
Newsfilter· 2025-02-05 13:00
Core Insights - Vaxcyte has advanced to Stage 2 of the Phase 2 study for VAX-31, a 31-valent pneumococcal conjugate vaccine designed to prevent invasive pneumococcal disease in infants [1][2][3] - The company expects to announce topline safety, tolerability, and immunogenicity data from the primary immunization series in mid-2026, followed by booster dose data approximately nine months later [1][2] - VAX-31 aims to cover approximately 94% of invasive pneumococcal disease and 93% of acute otitis media in U.S. children under five [1][6] Company Overview - Vaxcyte is a clinical-stage vaccine innovation company focused on developing high-fidelity vaccines to combat bacterial diseases [2][8] - The company is also developing VAX-24, a 24-valent pneumococcal conjugate vaccine, which is currently in a Phase 2 infant study [8] - Vaxcyte's technology aims to provide broader coverage against both currently circulating and historically prevalent strains compared to standard-of-care pneumococcal conjugate vaccines [2][3] Study Details - The VAX-31 infant Phase 2 study is a randomized, double-blind, active-controlled, dose-finding study evaluating safety, tolerability, and immunogenicity compared to Prevnar 20 [4] - Stage 1 assessed safety and tolerability in 48 infants across three ascending dose levels, while Stage 2 will include approximately 750 infants [4][10] - The study design follows ACIP recommendations, with a primary immunization series consisting of three doses at two, four, and six months, followed by a booster at 12-15 months [4] Disease Context - Pneumococcal disease, caused by Streptococcus pneumoniae, leads to significant morbidity and mortality, particularly in children under five [5][6] - It is a leading cause of vaccine-preventable deaths globally and is associated with high hospitalization rates in the U.S. [5] - The need for broader-spectrum vaccines is underscored by the emergence of antibiotic-resistant strains of Streptococcus pneumoniae [5][6] Product Development - VAX-31 is positioned as the broadest-spectrum pneumococcal conjugate vaccine candidate in clinical development, with potential to increase coverage by 12-40% over current adult vaccines [6][7] - The vaccine is designed to provide protection against over 95% of invasive pneumococcal disease circulating in adults aged 50 and older [6] - Vaxcyte's innovative approach includes modern synthetic techniques for vaccine production, aiming to enhance immunological benefits [9]
Vaxcyte to Present at the Guggenheim SMID Cap Biotech Conference
Globenewswire· 2025-01-30 21:05
Core Viewpoint - Vaxcyte, Inc. is a clinical-stage vaccine innovation company focused on developing high-fidelity vaccines to combat bacterial diseases, with upcoming participation in the Guggenheim SMID Cap Biotech Conference [1] Company Overview - Vaxcyte is engineering broad-spectrum conjugate and novel protein vaccines aimed at preventing or treating bacterial infectious diseases [3] - The company is developing VAX-31, a 31-valent PCV for preventing invasive pneumococcal disease (IPD) in adults and infants, and VAX-24, a 24-valent PCV currently in Phase 2 infant study [3] - Both VAX-31 and VAX-24 aim to improve upon existing PCVs by covering serotypes responsible for high case-fatality rates and antibiotic resistance [3] Technology and Innovation - Vaxcyte utilizes modern synthetic techniques, including advanced chemistry and the XpressCF™ cell-free protein synthesis platform, to produce complex vaccines more efficiently [4] - The company's approach is designed to enhance the immunological benefits of vaccines while accelerating the development process [4] Pipeline Candidates - Vaxcyte's pipeline includes VAX-A1 for preventing Group A Strep infections, VAX-PG for slowing periodontal disease progression, and VAX-GI for preventing Shigella [4]
Vaxcyte Aims To Outshine Pfizer With Bold VAX-31 Strategy
Seeking Alpha· 2025-01-15 12:15
Group 1 - The article emphasizes the importance of financial modeling techniques, particularly DCF analysis, to identify underlying assumptions in stock valuations [1] - A disciplined risk management strategy is advocated, utilizing a barbell approach that allocates 90% to safe assets and 10% to high-growth opportunities [1] - The DCF model assumes free cash flow starts at a baseline and grows at a constant annual rate over eight years, with a terminal value calculated using the Gordon Growth Model [1] Group 2 - Key assumptions in the DCF model include a constant growth rate and discount rate, with the discount rate exceeding the perpetual growth rate to ensure a finite terminal value [1] - The article highlights the need for accurate free cash flow projections to capture future performance without unexpected changes [1]
Vaxcyte Initiates Phase 2 Study Evaluating VAX-31 for the Prevention of Invasive Pneumococcal Disease in Infants
GlobeNewswire News Room· 2024-12-03 13:00
Core Insights - Vaxcyte has initiated a Phase 2 study for VAX-31, a 31-valent pneumococcal conjugate vaccine (PCV) aimed at preventing invasive pneumococcal disease (IPD) in infants, with topline data expected in mid-2026 and booster dose data approximately nine months later [1][2][3] - VAX-31 is designed to cover approximately 94% of IPD and 93% of acute otitis media in U.S. children under five, offering broader protection compared to current standard-of-care PCVs [2][7] - The study will compare VAX-31's safety, tolerability, and immunogenicity against Prevnar 20 (PCV20) in a randomized, double-blind format across two stages involving around 798 infants [3][4][5] 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 [9][10] - The company also has VAX-24, a 24-valent PCV candidate, which is in a Phase 2 study and aims to cover more serotypes than any existing infant PCV [9] - Vaxcyte employs modern synthetic techniques for vaccine development, including the XpressCF™ cell-free protein synthesis platform, to enhance the efficiency and immunological benefits of its vaccines [10] Industry Context - Pneumococcal disease, caused by Streptococcus pneumoniae, is a significant public health threat, particularly in children under five, leading to high rates of vaccine-preventable deaths globally [6] - The World Health Organization has identified Streptococcus pneumoniae as a top antibiotic-resistant pathogen, highlighting the urgent need for vaccines with broader coverage [6] - Current vaccines are insufficient to address the persistent threat of IPD, which includes severe conditions like meningitis and bacteremia, underscoring the importance of Vaxcyte's innovative vaccine candidates [2][6]
Vaxcyte Provides Positive Regulatory Updates on VAX-31 Pediatric and Adult Programs
GlobeNewswire News Room· 2024-11-12 12:30
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]
Vaxcyte(PCVX) - 2024 Q3 - Quarterly Report
2024-11-05 21:05
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 | --- | --- | |------------------------------------------------ ...
Vaxcyte Reports Third Quarter 2024 Financial Results and Provides Business Update
GlobeNewswire News Room· 2024-11-05 21:01
-- 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 ...
Vaxcyte's Broad-Spectrum Pneumococcal Vaccines Poised For Market Dominance By 2027
Seeking Alpha· 2024-09-08 13:00
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 ...