24-Valent Pneumococcal Polysaccharide Conjugate Vaccine(Vaxcyte)

SAN CARLOS, Calif., Sept. 04, 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, announced today the pricing of an underwritten public offering of common stock and pre-funded warrants. Vaxcyte is selling 10,194,175 shares of common stock and pre-funded warrants to purchase 2,427,184 shares of common stock in the offering. The shares of common stock are being sold at a public offering price of $103.00 per share, and the pre-funded warrants are being sold at a public offering price of $102.999 per pre-funded warrant. The exercise price of the pre-funded warrants is $0.001 per share. The aggregate gross proceeds to Vaxcyte from this offering are expected to be approximately $1.3 billion, before deducting underwriting discounts and commissions and other offering expenses, and excluding the exercise of any pre-funded warrants. All shares of common stock and pre-funded warrants to be sold in the offering will be offered by Vaxcyte. Vaxcyte has granted the underwriters a 30-day option to purchase up to an additional 1,893,203 shares of its common stock at the public offering price per share, less underwriting discounts and commissions. The offering is expected to close on September 6, 2024, subject to the satisfaction of customary closing conditions. 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. A shelf registration statement relating to the offered securities was filed with the Securities and Exchange Commission (SEC) and was automatically effective upon filing on May 24, 2024. A preliminary prospectus supplement and accompanying prospectus relating to the offering has been filed, and a final prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC and will be available on the SEC’s website, located at www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus relating to this offering may be obtained, when available, from BofA Securities NC1-022-02-25, Attention: Prospectus Department, 201 North Tryon Street, Charlotte, North Carolina 28255-0001 or by email at dg.prospectus_requests@bofa.com; Jefferies LLC, Attention: Equity Syndicate Department, 520 Madison Avenue, New York, New York 10022, by telephone at 1-877-821-7388, or by email at Prospectus_Department@Jefferies.com; Leerink Partners LLC, Attention: Syndicate Department, 53 State Street, 40th Floor, Boston, MA 02109, by email at syndicate@leerink.com or by phone at (800) 808-7525, ext. 6105; Goldman Sachs & Co. LLC, Attention: Prospectus Department, 200 West Street, New York, NY 10282, by email at prospectus-ny@ny.email.gs.com or by phone at (866) 471-2526; Evercore Group L.L.C., Attention: Equity Capital Markets, 55 East 52nd Street, 35th Floor, New York, New York 10055, by telephone at 1-888-474-0200 or by email at ecm.prospectus@evercore.com; Guggenheim Securities, LLC, Attention: Equity Syndicate Department, 330 Madison Avenue, 8th Floor, New York, NY 10017, by telephone at (212) 518-9544, or by email at GSEquityProspectusDelivery@guggenheimpartners.com; and Mizuho Securities USA LLC, 1271 Avenue of the Americas, Third Floor, New York, NY 10021, or by email at Us-ecm@mizuhogroup.com. This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. About Vaxcyte Vaxcyte is a vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases. The Company is developing broad-spectrum conjugate and novel protein vaccines to prevent or treat bacterial infectious diseases. VAX-31 is a Phase 3-ready 31-valent, carrier-sparing pneumococcal conjugate vaccine (PCV) being developed for the prevention of invasive pneumococcal disease (IPD) in adults and infants and is the broadest-spectrum PCV candidate in the clinic today. VAX-24, the Company’s 24-valent PCV candidate, is designed to cover more serotypes than any infant PCV on-market and is currently being evaluated in a Phase 2 infant study. Both VAX-31 and VAX-24 are designed to improve upon the standard-of-care PCVs by covering the serotypes in circulation that are responsible for a significant portion of IPD and are associated with high case-fatality rates, antibiotic resistance and meningitis, while maintaining coverage of previously circulating strains that are currently contained through continued vaccination practice. Vaxcyte is re-engineering the way highly complex vaccines are made through modern synthetic techniques, including advanced chemistry and the XpressCF™ cell-free protein synthesis platform, exclusively licensed from Sutro Biopharma, Inc. Unlike conventional cell-based approaches, the Company’s system for producing difficult-to-make proteins and antigens is intended to accelerate its ability to efficiently create and deliver high-fidelity vaccines with enhanced immunological benefits. Vaxcyte’s pipeline also includes VAX-A1, a prophylactic vaccine candidate designed to prevent Group A Strep infections; VAX-PG, a therapeutic vaccine candidate designed to slow or stop the progression of periodontal disease; and VAX-GI, a vaccine candidate designed to prevent Shigella. Vaxcyte is driven to eradicate or treat invasive bacterial infections, which have serious and costly health consequences when left unchecked. Contacts: Patrick Ryan, Executive Director, Corporate CommunicationsVaxcyte, Inc.415-606-5135media@vaxcyte.com Jennifer Zibuda, Senior Director, Investor RelationsVaxcyte, Inc.860-729-8902investors@vaxcyte.com

On September 3, Vaxcyte announced results from a direct comparison of its 31-valent pneumococcal conjugate vaccine, VAX-31, with Pfizer Prevnar 20. In Phase 1/2 clinical trials in adults 50 years of age and older, VAX-31 demonstrated excellent performance, meeting or exceeding immunogenicity standards for 31 serotypes in both the high-dose and medium-dose groups, and the vaccine was well tolerated. These results not only open up huge market potential for Vaxcyte, but also have the potential to reshape the pneumococcal vaccine landscape.   Pneumococcus is a major cause of invasive diseases, pneumonia and upper respiratory tract infections. Severe pneumococcal infection can lead to serious sequelae such as deafness, paralysis, and mental retardation. Pneumococcal vaccination is one of the most cost-effective and effective strategies to prevent such diseases. Pneumococcal vaccines are mainly divided into pneumococcal polysaccharide (PPV) vaccines and pneumococcal conjugate (PCV) vaccines, with the PCV vaccine dominating the market, while Pfizer's Prevnar series of vaccines occupy a leading position in the PCV vaccine market, including Prevnar 13 and Prevnar 20.   The Prevnar 20 vaccine is an iteration of the Prevnar 13 vaccine that covers seven additional serotypes (8, 10A, 11A, 12F, 15B, 22F, and 33F) that are associated with antibiotic resistance, disease severity, invasion potential, and prevalence of pediatric pneumococcal cases. The Prevnar 20 vaccine was approved by the U.S. Food and Drug Administration (FDA) in 2021 to prevent invasive disease and pneumonia caused by the 20 pneumococcal serotypes in the vaccine in adults 18 years of age and older, and was subsequently expanded to prevent pneumococcal infections in infants and young children.   In 2023, Pfizer's Prevnar series of vaccines reached $6.44 billion in sales, second only to Merck's HPV vaccine, and ranked second on the list of vaccine sales. The competitive focus of the next generation of PCV vaccines is mainly on the increase in the number of serotypes covered, which directly expands the protection of the vaccine.   According to a press release from Vaxcyte, the VAX-31 vaccine is a 31-valent pneumococcal conjugate vaccine capable of covering more than 95 percent of the invasive pneumococcal disease (IPD) serotypes prevalent in U.S. adults age 50 and older, with the potential to increase coverage by 12-40 percent over existing PCV vaccines. It is the broadest candidate for pneumococcal conjugate vaccine currently in clinical trials. The Phase 1/2 clinical study enrolled 1,015 healthy adults aged 50 years and older and was designed to evaluate the safety, tolerability and immunogenicity of VAX-31 versus Prevnar 20 (PCV20) at three doses. The study results showed that VAX-31 was well tolerated in all dose groups and showed a similar safety profile to Pfizer Prevnar 20 at all doses. For all 31 serotypes, VAX-31 exhibited a strong opsonophagocytosis (OPA) immune response in all dose groups.   For the 20 serotypes shared with PCV20, VAX-31 met the OPA response non-inferiority criteria at high doses for all 20 serotypes, with 18 serotypes having a geometric mean ratio (GMR) greater than 1.0 and 7 serotypes achieving a statistically higher immune response. At medium doses, all 20 serotypes met the OPA response non-inferiority criteria, 13 serotypes had GMR greater than 1.0, and 5 serotypes achieved a statistically higher immune response. At low doses, 18 serotypes met the OPA response non-inferiority criteria, 8 serotypes had GMR greater than 1.0, and 3 serotypes achieved a statistically higher immune response.   For the 11 additional serotypes unique to VAX-31, all three doses met the criteria for superiority. Based on these positive results, Vaxcyte plans to advance VAX-31 to a phase 3 clinical trial in adults. In addition to VAX-31, Vaxcyte is developing its 24-valent vaccine candidate, VAX-24, and expects to report safety and immunogenicity data from a Phase 2 infant study in the first quarter of 2025.