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Vaxcyte, Inc. (Nasdaq: PCVX) is a pioneering biopharmaceutical company based in San Carlos, California, dedicated to developing high-fidelity vaccines to protect against serious bacterial infections. Vaxcyte aims to improve global health through innovative vaccines designed to prevent diseases that conventional options fail to address effectively.
The company's flagship product, VAX-24, is a 24-valent pneumococcal conjugate vaccine (PCV) designed to provide broad-spectrum protection against invasive pneumococcal disease (IPD). VAX-24 is engineered to cover more strains than the current leading vaccines, addressing a significant unmet need in both adult and pediatric populations. Vaxcyte's advanced cell-free protein synthesis platform, XpressCF™, is pivotal in developing these complex conjugate vaccines, allowing for efficient production and enhanced immunogenicity.
Vaxcyte's pipeline includes VAX-31, a next-generation 31-valent PCV, currently in Phase 1/2 clinical trials. VAX-31 aims to achieve the broadest coverage of any PCV to date, targeting 95% of IPD strains circulating in the U.S. adult population. Additionally, the company is developing other promising vaccine candidates such as VAX-A1 for Group A Strep infections, VAX-PG for periodontal disease, and VAX-GI for Shigella prevention.
Recent milestones include the successful completion of enrollment in the VAX-31 Phase 1/2 trial and the VAX-24 infant Phase 2 study. The FDA granted Breakthrough Therapy designation to VAX-24, reflecting its potential to offer substantial improvements over existing treatments. Vaxcyte is on track to advance VAX-24 into Phase 3 trials, with topline data anticipated by 2025.
Financially, Vaxcyte is robust, supported by $1.4 billion in recent follow-on equity financings to advance its vaccine candidates and expand its manufacturing capabilities.
For more information, visit www.vaxcyte.com.
Vaxcyte, Inc. (Nasdaq: PCVX) announced a public offering of common stock and pre-funded warrants, with underwriters having a 30-day option to purchase an additional 15% of shares. The offering's terms are subject to market conditions and lack definitive timelines. Leading the offering are BofA Securities, Jefferies, and Evercore ISI. A shelf registration statement has been effective since July 2, 2021. The company's focus is on developing advanced vaccines, including its lead candidate, VAX-24, targeting invasive pneumococcal disease.
Vaxcyte, Inc. (Nasdaq: PCVX) announced the FDA's clearance of the Investigational New Drug application for VAX-24, its 24-valent pneumococcal conjugate vaccine. This marks a pivotal step as Vaxcyte transitions to a clinical-stage company. The Phase 1/2 clinical study is set to initiate in Q1 2022, with topline results expected by the end of the year. VAX-24 aims to address the significant public health challenge of pneumococcal disease, which affects hundreds of thousands annually in the U.S. The company is also advancing VAX-XP, designed to cover over 30 strains.
Vaxcyte, Inc. (Nasdaq: PCVX), a next-generation vaccine developer, will participate in several virtual investor conferences aimed at enhancing global health through innovative vaccine solutions. Key events include the Jefferies London Healthcare Conference from November 16-19, 2021, the Piper Sandler 33rd Annual Virtual Healthcare Conference from November 29-December 2, 2021, and the Evercore ISI 4th Annual HealthCONx Virtual Conference from November 30-December 2, 2021. Webcasts of these discussions will be available on Vaxcyte’s website for about 30 days.
Vaxcyte, Inc. (Nasdaq: PCVX) reported its Q3 2021 financials and business updates, announcing the completion of the GMP drug product manufacturing and GLP toxicology study for its VAX-24 vaccine. The company anticipates submitting the VAX-24 IND application to the FDA in Q1 2022. Q3 net loss was $26.6 million, compared to $21.0 million in Q3 2020. R&D expenses rose to $20.4 million from $16.4 million, attributed to personnel and project-related costs. Cash reserves as of September 30, 2021, were $318.3 million, down from $386.2 million at year-end 2020.
Vaxcyte, Inc. (Nasdaq: PCVX) announced the appointment of Carlos Paya as Board Chair and Michael Kamarck to its board of directors. Both leaders bring extensive experience in biopharmaceuticals and vaccine development. CEO Grant Pickering emphasized their expertise will help advance Vaxcyte’s mission to create next-generation vaccines, including the VAX-24 pneumococcal vaccine. The company aims to improve global health by developing superior vaccines targeting infectious diseases.
Vaxcyte, Inc. (Nasdaq: PCVX) announced participation in a fireside chat at the Guggenheim 2nd Annual Vaccine and Infectious Disease Conference on October 5, 2021, at 11:30 am ET. A live webcast will be available through the Company’s website, with a replay accessible for 30 days post-conference. Vaxcyte focuses on developing novel vaccines to combat infectious diseases, featuring advanced technologies like the XpressCF™ platform. Their lead candidate, VAX-24, targets invasive pneumococcal disease.
On September 21, 2021, Vaxcyte, Inc. (Nasdaq: PCVX) announced its participation in the 2021 Cantor Virtual Global Healthcare Conference. This event will take place on September 28, 2021, at 8:40 AM ET. A live webcast will be available on the company's website, with a replay accessible for 30 days post-conference. Vaxcyte is focused on developing advanced vaccines against common infectious diseases, with its lead candidate, VAX-24, targeting invasive pneumococcal disease.
Vaxcyte (Nasdaq: PCVX) announced the appointment of Annie Drapeau and Teri Loxam to its board of directors, following the departure of Patrick Heron and Rob Hopfner. CEO Grant Pickering expressed confidence in the new appointees' extensive experience in biopharmaceuticals and technology, which will support Vaxcyte's lead program, VAX-24, a pneumococcal conjugate vaccine. Drapeau previously led HR at Moderna, while Loxam is currently CFO at SQZ Biotechnologies, enhancing Vaxcyte's leadership at a pivotal time for its vaccine pipeline.
Vaxcyte, Inc. (Nasdaq: PCVX) announced its Q2 2021 financial results, reporting a net loss of $23.7 million, up from $20.3 million in Q2 2020. As of June 30, 2021, cash and investments stood at $341.0 million, down from $386.2 million at the end of 2020. The company is advancing its lead pneumococcal vaccine candidate, VAX-24, and is on track for an IND application submission between January and June 2022. Vaxcyte also secured an additional $3.2 million from CARB-X for VAX-A1, a vaccine targeting Strep infections. Operational expenses saw R&D at $17.7 million and G&A at $6.1 million.
Vaxcyte, Inc. (Nasdaq: PCVX) announced an additional $3.2 million grant from CARB-X, bringing total potential funding to $29.7 million for the development of its vaccine candidate, VAX-A1. This funding aims to enable the Investigational New Drug (IND) application for VAX-A1, a vaccine targeting Group A Streptococcus, which causes 700 million cases of illness annually. The vaccine is critical in addressing antibiotic resistance and reducing morbidity and mortality related to this widespread infection.
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