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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 announced significant regulatory updates for its VAX-31 pneumococcal conjugate vaccine (PCV) program. The FDA cleared the VAX-31 infant Investigational New Drug application and granted Breakthrough Therapy designation for adult indication. VAX-31, a 31-valent PCV candidate, is designed to cover approximately 94% of invasive pneumococcal disease (IPD) in U.S. children under five and over 95% of IPD in U.S. adults. The company plans to initiate the infant Phase 2 study by end of January 2025 and the adult Phase 3 pivotal study by mid-2025. Topline data from these studies are expected in 2026.
Vaxcyte (PCVX) reported Q3 2024 financial results and significant progress in its pneumococcal conjugate vaccine (PCV) programs. The company announced positive Phase 1/2 results for VAX-31, its 31-valent PCV candidate, in adults aged 50+. Based on these results, VAX-31 will advance to Phase 3 by mid-2025. Financial highlights include $3.3 billion in cash position, including $1.4 billion from a September public offering. Q3 R&D expenses were $116.9 million, G&A expenses $23.0 million, and net loss $103.1 million. The company expects key milestones including VAX-24 infant Phase 2 data by Q1 2025 and VAX-31 infant Phase 2 study initiation in Q1 2025.
Vaxcyte (Nasdaq: PCVX), a clinical-stage vaccine innovation company, has announced its participation in the 2024 Cantor Global Healthcare Conference. The company's management will engage in a fireside chat on Wednesday, September 18, at 10:20 a.m. ET / 7:20 a.m. PT.
Interested parties can access a live webcast of the discussion through the Investors & Media section of Vaxcyte's website at http://investors.vaxcyte.com. For those unable to attend the live event, a replay of the webcast will be available for approximately 30 days following the conference.
This presentation offers an opportunity for investors and analysts to gain insights into Vaxcyte's progress in developing high-fidelity vaccines aimed at protecting against bacterial diseases.
Vaxcyte (Nasdaq: PCVX) has successfully closed its previously announced public offering, raising approximately $1.5 billion in gross proceeds. The offering included 12,087,378 shares of common stock at $103.00 per share and pre-funded warrants to purchase 2,427,184 shares at $102.999 per warrant. Underwriters fully exercised their option to purchase an additional 1,893,203 shares. The offering was managed by several prominent financial institutions, including BofA Securities, Jefferies, and Leerink Partners. Vaxcyte, a clinical-stage vaccine innovation company, plans to use the funds to advance its high-fidelity vaccines aimed at protecting against bacterial diseases.
Vaxcyte (Nasdaq: PCVX) has announced the pricing of a $1.3 billion public offering of common stock and pre-funded warrants. The company is selling 10,194,175 shares of common stock at $103.00 per share and 2,427,184 pre-funded warrants at $102.999 each. The exercise price for the warrants is $0.001 per share. Vaxcyte has granted underwriters a 30-day option to purchase up to 1,893,203 additional shares. The offering is expected to close on September 6, 2024. Major financial institutions are acting as joint book-running managers for the offering.
Vaxcyte (Nasdaq: PCVX), a clinical-stage vaccine innovation company, has announced the commencement of a $1.0 billion underwritten public offering of its common stock and pre-funded warrants. The company plans to grant underwriters a 30-day option to purchase up to an additional $150.0 million of shares. BofA Securities, Jefferies, Leerink Partners, Goldman Sachs & Co. , Evercore ISI, Guggenheim Securities, and Mizuho are acting as joint book-running managers for the offering. The offering is subject to market conditions, and its completion, size, and terms are not guaranteed. A shelf registration statement has been filed with the SEC, and a preliminary prospectus supplement and accompanying prospectus will be available on the SEC's website.
Vaxcyte (NASDAQ: PCVX) announced positive topline results from its Phase 1/2 study of VAX-31, a 31-valent pneumococcal conjugate vaccine candidate, in adults aged 50 and older. The study demonstrated robust immune responses for all 31 serotypes at all doses, with middle and high doses meeting or exceeding regulatory immunogenicity criteria. VAX-31 showed a safety profile similar to Prevnar 20® and was well-tolerated. Based on these results, Vaxcyte has selected VAX-31 to advance to an adult Phase 3 program, with plans to initiate a pivotal, non-inferiority study by mid-2025 and announce topline data in 2026. The company also plans to initiate a VAX-31 infant Phase 2 study in Q1 2025 for the pediatric indication.
Vaxcyte (Nasdaq: PCVX) announced a webcast and conference call on September 3, 2024, at 8:00 a.m. Eastern Time to present topline results from the Phase 1/2 study of VAX-31, their 31-valent pneumococcal conjugate vaccine (PCV) candidate. The study evaluated the safety, tolerability, and immunogenicity of VAX-31 in healthy adults aged 50 and older. VAX-31 is designed to prevent invasive pneumococcal disease (IPD). Interested parties can participate via phone (800-225-9448 domestic, 203-518-9708 international) using conference ID PCVX0903 or through a live webcast on Vaxcyte's investor relations page. The webcast will be archived for 30 days after the event.
Vaxcyte (PCVX) reported Q2 2024 financial results and provided a business update. Key highlights include:
- VAX-31 adult Phase 1/2 study topline data expected in September 2024
- VAX-24 infant Phase 2 study topline data expected by Q1 2025
- $1.9 billion in cash and investments as of June 30, 2024
- R&D expenses increased to $131.5 million in Q2 2024
- Net loss widened to $128.7 million in Q2 2024
The company plans to advance either VAX-24 or VAX-31 to Phase 3 in adults following the VAX-31 data readout. Vaxcyte also appointed John Furey to its Board of Directors and received a $9.5 million NIAID grant for Chlamydia vaccine development.
Vaxcyte has appointed John Furey to its Board of Directors, effective July 2, 2024. Furey brings extensive experience in the biopharmaceutical and vaccine sectors, especially in the manufacture, supply, and commercialization of pneumococcal conjugate vaccines (PCVs). This addition comes as Vaxcyte advances its PCV candidates, VAX-24 and VAX-31, towards late-stage clinical development. Furey's expertise is expected to provide strategic insights and strengthen the company’s efforts in developing innovative vaccines using a cell-free technology platform.
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