PCV15

Vaxcyte Reports First Quarter 2024 Financial Results and Provides Business Update

Retrieved on: 
Wednesday, May 8, 2024
Vaccination, Public, Advisory Committee, Net, Ageing, Tolerability, Investment, PCV15, PCV, Safety, Phase 10, Infant, Infection, Trial of the century, Conference, Growth, Administration, Lonza, Immunization, Exercise, Research and development, Bank, ACIP, Stage 2, Initiate, PCV20, G&A, SAN, End, Genetically modified bacteria, IPD, Vaccine

SAN CARLOS, Calif., May 08, 2024 (GLOBE NEWSWIRE) --  Vaxcyte, Inc. (Nasdaq: PCVX), a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases, today announced financial results for the first quarter ended March 31, 2024, and provided a business update.

Key Points: 
  • “We also continue to progress our early-stage pipeline led by VAX-A1, a vaccine candidate designed to prevent Group A Strep infections.
  • The aggregate gross proceeds to Vaxcyte from this offering were $862.5 million, before deducting underwriting discounts and commissions and other offering expenses payable by Vaxcyte.
  • The March 31, 2024 amount includes the $816.5 million in net proceeds from the follow-on offering completed in February 2024.
  • As of March 31, 2024, Vaxcyte had incurred $101.8 million in total capital and facility buildout expenditures that were reflected on the Company’s balance sheet as of that date.

Vaxcyte Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Business Update

Retrieved on: 
Tuesday, February 27, 2024
Licensure, Investment, Growth, Exercise, Tolerability, Immunization, Host, Trial of the century, Ageing, PCV20, PCV, P-value, Safety, BLA, Success, Phase 10, Genetically modified bacteria, Net, G&A, CMC, SAN, Research and development, ID, OPA, Conference, The Lancet, Biologics license application, Breakthrough therapy, Advisory Committee, PCV15, POC, FDA, End, Food, Breakthrough, Element, Fireside chats, Administration, IPD

-- Significant Progress in Establishing Global Commercial Manufacturing Capacity for Vaxcyte's PCV Candidates, Including Expanded Collaboration with Lonza --

Key Points: 
  • ET / 1:30 p.m. PT --
    SAN CARLOS, Calif., Feb. 27, 2024 (GLOBE NEWSWIRE) -- Vaxcyte, Inc. (Nasdaq: PCVX), a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases, today announced financial results for the fourth quarter and full year ended December 31, 2023, and provided a business update.
  • Additionally, as part of ongoing Chemistry, Manufacturing and Controls (CMC)-focused discussions, Vaxcyte received encouraging input from the FDA regarding the VAX-24 adult licensure requirements.
  • The six-month safety data from both studies showed safety and tolerability results for VAX-24 similar to PCV20 at all doses studied.
  • Vaxcyte will host a conference call and webcast to discuss this announcement today, February 27, 2024, at 4:30 p.m.

Vaxcyte Provides Clinical and Regulatory Progress Update on Potential Best-in-Class Pneumococcal Conjugate Vaccine (PCV) Franchise

Retrieved on: 
Thursday, January 4, 2024
Licensure, Food, PCV, End, Breakthrough therapy, FDA, CMC, Ageing, Phase 10, SAN, Pivotal, Biologics license application, Advisory Committee, PCV20, Breakthrough, Data monitoring committee, Immunization, Initiation, IPD, PCV15, Infant, Safety, Tolerability, Genetically modified bacteria, BLA, Vaccine

-- Enrollment in Ongoing VAX-24 Infant Phase 2 Study Continues to Progress; Topline Data from Primary Immunization Series Expected by End of First Quarter of 2025, Followed by Topline Data from Booster Dose by End of 2025 --

Key Points: 
  • Vaxcyte’s carrier-sparing PCV franchise candidates, including VAX-24, a 24-valent PCV proceeding to Phase 3, and VAX-31, the Company’s next-generation 31-valent PCV, are being studied for the prevention of invasive pneumococcal disease (IPD).
  • The VAX-24 Phase 2 infant study continues to enroll participants in the second and final stage of the study.
  • This is a randomized, observer-blind, dose-finding two-stage clinical study evaluating the safety, tolerability and immunogenicity of VAX-24 in healthy infants.
  • Topline safety, tolerability and immunogenicity data from the ongoing adult Phase 1/2 study in the third quarter of 2024.

Vaxcyte Advances to Second Stage of Ongoing Phase 2 Study Evaluating VAX-24 for the Prevention of Invasive Pneumococcal Disease in Infants

Retrieved on: 
Tuesday, July 11, 2023
ACIP, IPD, Public, Advisory Committee, Stage 2, Data monitoring committee, Genetically modified bacteria, PCV20, Advisory Committee on Immunization Practices, SAN, Peterborough, PCV15, PCV, FDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, News, Meningitis, Food, Safety, Disease, Vaccine, Pharmaceutical industry

SAN CARLOS, Calif., July 11, 2023 (GLOBE NEWSWIRE) -- Vaxcyte, Inc. (Nasdaq: PCVX), a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases, today announced that the ongoing Phase 2 study of VAX-24 in healthy infants is advancing to the second and final stage of the study. The independent Data Safety Monitoring Board approved advancing to the second stage of the study following the review of the safety and tolerability results from the first stage. The Phase 2 study is evaluating the safety, tolerability and immunogenicity of VAX-24, the Company’s lead, broad-spectrum 24-valent pneumococcal conjugate vaccine (PCV) candidate designed to prevent invasive pneumococcal disease (IPD). Vaxcyte expects to share topline data from the primary three-dose immunization series of the study by 2025, followed by topline data from the booster dose approximately nine months later.

Key Points: 
  • The independent Data Safety Monitoring Board approved advancing to the second stage of the study following the review of the safety and tolerability results from the first stage.
  • The Phase 2 study is evaluating the safety, tolerability and immunogenicity of VAX-24, the Company’s lead, broad-spectrum 24-valent pneumococcal conjugate vaccine (PCV) candidate designed to prevent invasive pneumococcal disease (IPD).
  • The Stage 2 portion is evaluating the safety, tolerability and immunogenicity of VAX-24 at the same three dose levels compared to PCV20 in approximately 750 infants.
  • “We believe the findings from our Phase 2 infant study will provide valuable insights into the potential utility of VAX-24, the broadest-spectrum PCV in U.S. clinics today.”

Vaxcyte Reports First Quarter 2023 Financial Results and Provides Business Update

Retrieved on: 
Monday, May 8, 2023
Exercise, OPA, Research and development, P-value, Solar eclipse of March 31, 2090, Investment, IPD, Safety, Pneumococcal conjugate vaccine, Ageing, G&A, Element, Breakthrough therapy, Genetically modified bacteria, PCV20, Safety data sheet, Administration, SAN, Peterborough, Growth, R, PCV, STS, FDA, General Administration of Sport of China, Immunization, IND, Vaccine, Pharmaceutical industry, Cryptocurrency, PCV15, Infant

-- $949.9 Million in Cash, Cash Equivalents and Investments as of March 31, 2023, Excluding Net Proceeds of $545.1 Million from Recent Public Offering --

Key Points: 
  • VAX-24, the Company’s lead, broad-spectrum 24-valent pneumococcal conjugate vaccine (PCV) candidate, is being studied for the prevention of IPD.
  • Submission of the adult IND application to the FDA and announcement of subsequent FDA clearance in the second half of 2023.
  • The March 31, 2023 amount excludes the $545.1 million in estimated net proceeds from the follow-on offering completed in April 2023.
  • Net Loss: For the three months ended March 31, 2023, net loss was $60.5 million, compared to $39.0 million for the same period in 2022.

Vaxcyte Doses First Participants in Phase 2 Study Evaluating VAX-24 for the Prevention of Invasive Pneumococcal Disease in Infants

Retrieved on: 
Thursday, March 30, 2023
Vaccine, Life, IPD, Tolerability, Trial of the century, Genetically modified bacteria, Fungal infection, SAN, PCV15, PCV, Immunization, Meningitis, Safety, Disease

SAN CARLOS, Calif., March 30, 2023 (GLOBE NEWSWIRE) -- Vaxcyte, Inc. (Nasdaq: PCVX), a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases, today announced that the first participants were dosed in the Phase 2 study of VAX-24 in healthy infants. This study will evaluate the safety, tolerability and immunogenicity of VAX-24, the Company’s lead, broad-spectrum 24-valent pneumococcal conjugate vaccine (PCV) candidate designed to prevent invasive pneumococcal disease (IPD). The Company expects to share topline data from the primary three-dose immunization series of the Phase 2 study by 2025.

Key Points: 
  • This study will evaluate the safety, tolerability and immunogenicity of VAX-24, the Company’s lead, broad-spectrum 24-valent pneumococcal conjugate vaccine (PCV) candidate designed to prevent invasive pneumococcal disease (IPD).
  • The Company expects to share topline data from the primary three-dose immunization series of the Phase 2 study by 2025.
  • Vaxcyte’s Phase 2 infant study is being conducted in two stages and compares VAX-24 to the broadest standard-of-care PCV, which is currently PCV15.
  • The study design includes a primary immunization series consisting of three doses followed by a subsequent booster dose.