PCVX

Topline Safety, Tolerability and Immunogenicity Data from VAX-31 Adult Phase 3 OPUS-1 Trial Expected in Fourth Quarter of 2026; OPUS-2 and OPUS-3 Phase 3 Results Expected in First Half of 2027 Topline Safety, Tolerability and Immunogenicity Data from Primary Immunization Series and Booster Dose of VAX-31 Infant Phase 2 Dose-Finding Study Expected Either Sequentially or Together by End of First Half of 2027 Company Initiated Phase 1 Study Evaluating VAX-A1 for the Prevention of Disease Caused by Group A Streptococcus in Healthy Adults; Topline Data Expected in Second Half of 2027 Approximately $2.5 Billion in Cash, Cash Equivalents and Investments as of June 30, 2026 SAN CARLOS, Calif., Aug. 05, 2026 (GLOBE NEWSWIRE) -- Vaxcyte, Inc. (Nasdaq: PCVX), a clinical-stage vaccine innovation company, today announced financial results for the second quarter ended June 30, 2026, and provided a business update. "With the VAX-31 OPUS-1, OPUS-2 and OPUS-3 Phase 3 trials and the VAX-31 Phase 2 infant study fully enrolled, we expect a series of meaningful clinical study readouts across our adult and infant pneumococcal conjugate vaccines (PCV) franchise over the next 12 months," said Grant Pickering, Chief Executive Officer and Co-Founder of Vaxcyte. "We are on track to deliver the topline data from the OPUS-1 noninferiority trial in the fourth quarter of this year. Following, we expect to announce the results of the OPUS-2 and OPUS-3 trials in the first half of 2027, which along with a manufacturing consistency study, would enable our planned Biologics License Application (BLA) submission and potential U.S. commercial launch." "With $2.5 billion in cash, cash equivalents and investments as of June 30, 2026, we maintain a strong balance sheet and are well positioned to execute on our planned clinical, manufacturing and commercial-readiness milestones across our PCV development programs," said Andrew Guggenhime, President and Chief Financial Officer of Vaxcyte. "As we prepare for the Company’s next phase of growth, we continue to advance our early-stage pipeline, including VAX-A1, a prophylactic vaccine candidate designed to prevent disease caused by Group A Strep, now in a Phase 1 adult study, and VAX-XL, our preclinical, next-generation PCV candidate designed to provide the broadest coverage of any PCV currently in development." Key Second Quarter and Recent Highlights PCV Franchise Adult Indication: Enrollment Completed for Three VAX-31 Adult Phase 3 OPUS Trials; Topline Data from OPUS-1 Expected in Fourth Quarter 2026: All three ongoing VAX-31 Phase 3 clinical trials (OPUS-1, OPUS-2 and OPUS-3) are fully enrolled with 6,191 adults dosed in total, approximately 3,500 of whom received VAX-31. These studies, which were finalized in consultation and alignment with the U.S. Food and Drug Administration (FDA), are designed to generate a broad and robust safety, tolerability and immunogenicity dataset. In addition, the Company is planning a manufacturing consistency study (e.g., a lot-to-lot study) as the final Phase 3 study to enable the submission of the BLA. The OPUS-1 Phase 3 pivotal, noninferiority trial, in which 4,049 participants were dosed, is evaluating the safety, tolerability and immune responses of VAX-31 in healthy, pneumococcal-naïve1 U.S. adults aged 50 years and older through direct, head-to-head comparisons with both Prevnar 20® (PCV20) and Capvaxive® (PCV21), the current standard-of-care PCVs, with the objective of establishing a best-in-class profile for VAX-31. The trial is also evaluating the safety, tolerability and immune responses of VAX-31 in a separate cohort of adults aged 18-49. The OPUS-2 Phase 3 study, in which 1,390 participants were dosed, is evaluating the safety, tolerability and immunogenicity of VAX-31 when administered either concomitantly with or one month following administration of a licensed seasonal influenza vaccine in healthy, pneumococcal-naïve U.S. adults aged 50 years and older. The results of this descriptive study are intended to inform the design of a potential post-licensure outcomes study that further evaluates VAX-31 in concomitant use with an influenza vaccine and to provide supportive evidence as part of the broader Phase 3 dataset. The OPUS-3 Phase 3 descriptive study, in which 752 participants were dosed, is evaluating the safety, tolerability and immunogenicity of VAX-31 in healthy U.S. adults aged 50 years and older who have previously received pneumococcal vaccination, including whether VAX-31 can expand the breadth of protection and boost responses to the serotypes included in the lower-valency pneumococcal vaccines. Early-Stage Pipeline: Initiated Phase 1 Study Evaluating VAX-A1, a Potential Best-in-Class Vaccine Candidate Designed to Provide Broad Protection Against Disease Caused by Group A Streptococcus: In June 2026, the Company announced that the first participant was dosed in the Phase 1, first-in-human study evaluating VAX-A1, an investigational prophylactic vaccine candidate for the prevention of disease caused by Group A Streptococcus (Group A Strep or Streptococcus pyogenes), in healthy adults aged 18 to 40 years. All participants enrolled in Stage 1 of the study have received the first of two planned doses. The Stage 2 portion of the study is expected to proceed contingent upon the Data Safety Monitoring Board’s approval following the review of unblinded Stage 1 safety and tolerability data. All participants in the study will be evaluated for safety through six months after receiving the second dose. The primary objective of this randomized, double-blind, placebo-controlled, dose-escalation, two-stage study is to assess the safety and tolerability of VAX-A1, along with a secondary objective of evaluating initial immunogenicity data, to support potential further advancement. This approach is designed to generate comprehensive initial safety data and provide a foundation for evaluating next steps in the program’s development. Group A Strep remains a major global cause of morbidity and mortality in adults and children and is a leading driver of antibiotic use, underscoring the significant public health burden. Board of Directors: Appointment and Retirement of Directors: The Board of Directors has appointed two new members, Dr. Moncef Slaoui and Dr. John Markels, to replace retiring members, Mr. Jacks Lee and Dr. Heath Lukatch. The Company thanks both retiring members for their considerable contributions during their service. Dr. Slaoui most recently served as Chief Scientific Advisor of Operation Warp Speed, the U.S. government effort to accelerate the development of COVID-19 vaccines. Prior to that, Dr. Slaoui spent nearly 30 years at GlaxoSmithKline, where he served as a member of the board of directors of GSK plc; Chairman of Pharmaceutical R&D; Chairman of Global R&D, Vaccines and Oncology; and Chairman of Global Vaccines, during which he was directly involved in building the company's vaccine pipeline. Dr. John Markels brings over 35 years of leadership experience in the pharmaceutical industry, including a longstanding tenure with Merck where he most recently served as President of Merck Global Vaccines. He has worked across global commercial leadership, strategy and organizational development, as well as manufacturing, development and technology transfer. Anticipated Program Milestones Vaxcyte is advancing the clinical development of its pipeline programs with several key milestones anticipated: VAX-31 Adult Indication Announce topline safety, tolerability and immunogenicity data from the OPUS-1 Phase 3 pivotal, noninferiority trial in fourth quarter of 2026. Announce safety, tolerability and immunogenicity data from the OPUS-2 and OPUS-3 Phase 3 trials in the first half of 2027. VAX-31 Infant Indication Announce topline safety, tolerability and immunogenicity data from the VAX-31 infant Phase 2 randomized, dose-finding study from both the primary three-dose immunization series and booster dose either sequentially or together by the end of the first half of 2027. VAX-A1 Announce topline data from the Phase 1 study in adults in the second half of 2027. Second Quarter 2026 Financial Results Cash Position: Cash, cash equivalents and investments were $2,507.7 million as of June 30, 2026, compared to $2,442.6 million as of December 31, 2025. Research & Development (R&D) Expenses: R&D expenses were $267.9 million for the three months ended June 30, 2026 as compared to $194.2 million for the same period in 2025. The increase was due primarily to higher development and product manufacturing costs associated with the Company's PCV programs, including for manufacturing activities to support the potential future commercial launches and clinical trial expenses primarily related to the VAX-31 OPUS Phase 3 trials, as well as higher personnel expenses related to the growth in the number of R&D employees. General & Administrative (G&A) Expenses: G&A expenses were $34.9 million for the three months ended June 30, 2026 as compared to $32.0 million for the same period in 2025. The increase was due primarily to higher personnel expenses related to the growth in the number of G&A employees. Net Loss: For the three months ended June 30, 2026, net loss was $284.3 million, compared to $166.6 million for the same period in 2025. About Vaxcyte Vaxcyte is a vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases. VAX-31, a 31-valent PCV candidate being evaluated in the OPUS Phase 3 adult clinical program and in a Phase 2 infant clinical program, is being developed for the prevention of invasive pneumococcal disease (IPD) and is the broadest-spectrum PCV candidate in the clinic today. VAX-24, a 24-valent PCV candidate, is designed to cover more serotypes than any infant PCV on-market. VAX-31 and VAX-24 are designed to improve upon standard-of-care PCVs by covering the serotypes in circulation that cause a significant portion of IPD and are associated with high case-fatality rates, antibiotic resistance and meningitis, while maintaining coverage of previously circulating strains. VAX-XL, in earlier-stage development, also leverages the Company’s carrier-sparing, site-specific conjugation technology with the aim of further expanding coverage to deliver the broadest-spectrum candidate in the Company’s PCV franchise. VAX-A1 is a prophylactic vaccine candidate designed to provide broad, strain-independent protection against disease caused by Group A Strep and is currently being evaluated in a Phase 1 clinical study in adults. Group A Strep remains a significant global cause of morbidity and mortality across both adult and pediatric populations and is a leading driver of antibiotic use, underscoring the substantial public health burden. Vaxcyte is re-engineering the way highly complex vaccines are made through XpressCF®, its 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 develop high-fidelity vaccines with enhanced immunological benefits. Vaxcyte’s pipeline also includes VAX-GI, a vaccine candidate designed to prevent Shigella. For more information, visit www.vaxcyte.com. Forward-Looking Statements This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements related to the potential benefits of Vaxcyte’s carrier-sparing platform and vaccine candidates, including breadth of coverage, the ability to deliver potentially best-in-class vaccines and improve upon the standard-of-care; the design, timing of initiation, progress and expected results of Vaxcyte's clinical trials and regulatory plans; the future commercialization of Vaxcyte’s PCV programs; Vaxcyte’s cash runway; and other statements that are not historical fact. The words “anticipate,” “believe,” “could,” “expect,” “intend,” “may,” “on track,” “potential,” “should,” “would” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) convey uncertainty of future events or outcomes and are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These forward-looking statements are based on Vaxcyte’s current expectations and actual results and timing of events could differ materially from those anticipated in such forward-looking statements as a result of risks and uncertainties, including, without limitation, risks related to Vaxcyte’s product development programs, including development timelines, success and timing of chemistry, manufacturing and controls and related manufacturing activities, potential delays or inability to obtain and maintain required regulatory approvals for its vaccine candidates, and the risks and uncertainties inherent with preclinical and clinical development processes; the success, cost and timing of all development activities and clinical trials; and sufficiency of cash and other funding to support Vaxcyte’s development programs and other operating expenses. These and other risks are described more fully in Vaxcyte’s filings with the Securities and Exchange Commission (SEC), including its Quarterly Report on Form 10-Q filed with the SEC on August 5, 2026 or in other documents Vaxcyte subsequently files with or furnishes to the SEC. All forward-looking statements contained in this press release speak only as of the date on which they were made and are based on management’s assumptions and estimates as of such date, and readers should not rely upon the information in this press release as current or accurate after its publication date. Vaxcyte undertakes no duty or obligation to update any forward-looking statements contained in this release as a result of new information, future events or changes in its expectations. Readers should not rely upon the information in this press release as current or accurate after its publication date. Contacts: Patrick Ryan, Executive Director, Corporate Affairs Vaxcyte, Inc. 415-606-5135 [email protected] Jeff Macdonald, Executive Director, Investor RelationsVaxcyte, [email protected] ___________________________________________ (1) Amounts include stock-based compensation expense as follows: ___________________________________________ 1 Pneumococcal-naïve is defined as having no known prior history of IPD or pneumococcal pneumonia, or receipt of any licensed or investigational pneumococcal vaccine.

On May 15, 2026, Deep Track Capital disclosed a new position in Alumis (NASDAQ:ALMS), acquiring 6,772,595 shares—an estimated $169.31 million trade based on quarterly average pricing. According to a May 15, 2026 SEC filing, Deep Track Capital reported acquiring 6,772,595 shares of Alumis (NASDAQ:ALMS) during the first quarter of 2026. The estimated transaction value was $169.31 million, based on the period’s average unadjusted closing price. As of March 31, 2026, the fund’s Alumis stake was valued at $149.20 million, reflecting both the purchase and stock price changes during the quarter. Top five holdings after the filing: As of Friday, shares of Alumis were priced at $22.02, up about 355% over the past year and well outperforming the S&P 500, which is up about 28% in the same period. Alumis develops clinical-stage biopharmaceutical products targeting autoimmune and neuroinflammatory diseases, with lead assets including ESK-001 and A-005. The firm operates a research-driven business model focused on advancing proprietary TYK2 inhibitors through clinical trials toward potential commercialization. It targets healthcare providers and patients affected by autoimmune disorders such as plaque psoriasis, systemic lupus erythematosus, and neurodegenerative diseases. Alumis is a biotechnology company specializing in the development of novel therapies for autoimmune and neuroinflammatory conditions. It leverages expertise in allosteric TYK2 inhibition to advance a pipeline of differentiated clinical candidates. With a focus on unmet medical needs, Alumis aims to establish a competitive edge through innovative science and targeted clinical development strategies. Deep Track has a history of making concentrated healthcare investments, and Alumis fits that playbook as a late-stage biotech with multiple shots on goal and several potentially value-defining catalysts over the next year.The story is increasingly centered on envudeucitinib, the company's TYK2 inhibitor for autoimmune diseases. Recent Phase 3 psoriasis data showed PASI 90 response rates of 68.0% and 62.1% by Week 24, with PASI 100 rates reaching 41.0% and 39.5%. Management says it remains on track to submit an NDA in the fourth quarter of this year, while potentially pivotal Phase 2b lupus data are expected in the third quarter.CEO Martin Babler said the results reinforce the drug's potential to "reshape the psoriasis treatment landscape" and described envudeucitinib as a potential "pipeline in a pill" with opportunities across additional immune-mediated diseases.Financially, Alumis ended the quarter with $569.5 million in cash, cash equivalents, and marketable securities and expects that capital to fund operations into the fourth quarter of 2027.For long-term investors, the thesis is straightforward. If upcoming lupus data and the planned psoriasis filing go well, today's valuation could look conservative. If either disappoints, the stock's remarkable run may prove difficult to sustain. Before you buy stock in Alumis, consider this: The Motley Fool Stock Advisor analyst team just identified what they believe are the 10 best stocks for investors to buy now… and Alumis wasn’t one of them. The 10 stocks that made the cut could produce monster returns in the coming years. Consider when Netflix made this list on December 17, 2004... if you invested $1,000 at the time of our recommendation, you’d have $477,813!* Or when Nvidia made this list on April 15, 2005... if you invested $1,000 at the time of our recommendation, you’d have $1,320,088!* Now, it’s worth noting Stock Advisor’s total average return is 986% — a market-crushing outperformance compared to 208% for the S&P 500. Don't miss the latest top 10 list, available with Stock Advisor, and join an investing community built by individual investors for individual investors. See the 10 stocks » *Stock Advisor returns as of May 24, 2026. Jonathan Ponciano has no position in any of the stocks mentioned. The Motley Fool has positions in and recommends Guardant Health. The Motley Fool has a disclosure policy. This Biotech Stock Is Up 355%. One Fund Added a $169 Million Position Last Quarter was originally published by The Motley Fool

Enrollment Now Completed for OPUS-1, OPUS-2 and OPUS-3 Phase 3 Trials Evaluating VAX-31 for the Prevention of Invasive Pneumococcal Disease and Pneumonia in Adults Topline Safety, Tolerability and Immunogenicity Data from OPUS-1 Expected in Fourth Quarter of 2026; OPUS-2 and OPUS-3 Results Expected in First Half of 2027 Enrollment Completed for VAX-31 Infant Phase 2 Dose-Finding Study; Topline Safety, Tolerability and Immunogenicity Data from Primary Immunization Series and Booster Dose Expected Either Sequentially or Together by End of First Half of 2027 Company Expects to Initiate Phase 1 Adult Clinical Study for VAX-A1, a Vaccine Candidate to Prevent Disease Caused by Group A Strep, in Mid-2026 Approximately $2.7 Billion in Cash, Cash Equivalents and Investments as of March 31, 2026, Including $601.8 Million in Net Proceeds from February 2026 Equity Offering SAN CARLOS, Calif., May 06, 2026 (GLOBE NEWSWIRE) -- Vaxcyte, Inc. (Nasdaq: PCVX), a clinical-stage vaccine innovation company, today announced financial results for the first quarter ended March 31, 2026, and provided a business update. "With the recent completion of OPUS-3 enrollment, our OPUS-1, OPUS-2 and OPUS-3 adult Phase 3 trials are now fully enrolled, and we remain on track to deliver data from these studies beginning with the expected OPUS-1 topline readout in the fourth quarter," said Grant Pickering, Chief Executive Officer and Co-Founder of Vaxcyte. "Our OPUS Phase 3 program was designed to establish not only a best-in-class pneumococcal conjugate vaccine (PCV), but also a new standard by which other pneumococcal vaccines will be judged. Based on the unprecedented results from our VAX-31 Phase 1/2 study in adults and the advantages of our carrier-sparing platform, we designed the OPUS-1 noninferiority trial as a head-to-head comparison against both Prevnar 20® (PCV20) and Capvaxive® (PCV21) with the potential to deliver a 14-34% increase in coverage against invasive pneumococcal disease (IPD) and a 19-31% increase in coverage against pneumococcal pneumonia relative to the current standard-of-care PCVs in U.S. adults. Following the anticipated OPUS-1 data in the fourth quarter, we expect to announce the results of the OPUS-2 and OPUS-3 Phase 3 trials in the first half of 2027, maintaining the timeline for our planned Biologics Application License (BLA) submission and potential U.S. commercial launch." "In the first quarter of 2026, we completed an equity financing that further strengthened our balance sheet and extended our cash runway," said Andrew Guggenhime, President and Chief Financial Officer of Vaxcyte. "With $2.7 billion in cash, cash equivalents and investments as of March 31, 2026, we are well positioned to execute on our planned clinical, manufacturing and commercial readiness milestones for our PCV development programs and support the Company’s next phase of growth. This includes advancing VAX-A1, a prophylactic vaccine candidate designed to prevent disease caused by Group A Strep, into the clinic in mid-2026." Key First Quarter and Recent Highlights PCV Franchise Adult Indication: Advanced Comprehensive VAX-31 Phase 3 Adult Clinical Program to Support Planned BLA Submission, with Enrollment Completed for Three OPUS Trials: All three ongoing VAX‑31 Phase 3 clinical trials (OPUS-1, OPUS-2 and OPUS-3) are now fully enrolled with 6,191 adults dosed in total, approximately 3,500 of whom received VAX-31. These studies, which were finalized in consultation and alignment with the U.S. Food and Drug Administration (FDA), are designed to generate a broad and robust safety, tolerability and immunogenicity dataset. In addition, the Company is also planning a manufacturing consistency study (e.g., a lot-to-lot study) as the final Phase 3 study. In March 2026, the Company announced the completion of enrollment in the OPUS-1 Phase 3 pivotal, noninferiority trial with 4,049 participants dosed and the OPUS-2 Phase 3 trial evaluating VAX-31 concomitantly administered with a seasonal influenza vaccine with 1,390 participants dosed. OPUS-1 is evaluating the safety, tolerability and immune responses of VAX-31 in healthy, pneumococcal-naïve1 adults aged 50 and older through direct, head-to-head comparisons with both PVC20 and PCV21, the current standard-of-care PCVs, with the objective of establishing a best-in-class profile for VAX-31. The trial is also evaluating the safety, tolerability and immune responses of VAX-31 in a separate cohort of adults aged 18-49. OPUS-2 is evaluating the safety, tolerability and immunogenicity of VAX-31 when administered either concomitantly with or one month following administration of a licensed seasonal influenza vaccine in pneumococcal-naïve, healthy U.S. adults aged 50 years and older. The results of this descriptive study are intended to inform the design of a potential post-licensure outcomes study that further evaluates VAX-31 in concomitant use with an influenza vaccine and to provide supportive evidence as part of the broader Phase 3 dataset. The Company recently completed enrollment in the OPUS-3 trial, a Phase 3 descriptive study evaluating the safety, tolerability and immunogenicity of VAX-31 in adults who have previously received pneumococcal vaccination, including whether VAX-31 can expand the breadth of protection and boost responses to the serotypes included in the lower-valency pneumococcal vaccines that participants previously received. In the study, 752 adults aged 50 years and older who have previously received lower-valency pneumococcal vaccines were dosed. Positive VAX-31 Phase 1/2 Adult Data Published in The Lancet Infectious Diseases: In March 2026, the Company announced the publication of results from the positive VAX-31 adult Phase 1/2 clinical study in the journal The Lancet Infectious Diseases. The study results showed that VAX-31 at all doses studied was observed to be well tolerated and demonstrated a safety profile similar to PCV20 through the full six-month evaluation period. At all doses studied, VAX-31 demonstrated robust opsonophagocytic activity (OPA) and immunoglobulin G (IgG) immune responses, with high geometric mean concentrations (GMCs) across all 31 serotypes. The VAX-31 High Dose, which is currently being evaluated in the VAX-31 adult OPUS Phase 3 program, met or exceeded the OPA response noninferiority criteria2 for all 20 serotypes common with PCV20 and met the superiority criteria3 for the 11 incremental serotypes unique to VAX-31 and not in PCV20. The VAX-31 High Dose average OPA immune responses were greater for 18 of 20 serotypes compared to PCV20 (geometric mean ratio (GMR) greater than 1.0), with seven of these serotypes achieving statistically higher immune responses4 compared to PCV20. PCV Franchise Infant Indication: Completed Enrollment in VAX-31 Infant Phase 2 Study: In January 2026, the Company announced the completion of enrollment in the VAX-31 infant Phase 2 dose-finding study, with 900 healthy infants dosed. Participants have received at least their second dose in the primary immunization series. VAX-31 is designed to substantially expand coverage in the pediatric population by adding 11 incremental serotypes over and above today's standard-of-care, PCV20. VAX-31 has the potential to increase protection against IPD from approximately 69% to approximately 92% of disease circulating in children under five years of age in the U.S. and increase protection against acute otitis media from approximately 61% to approximately 96% in U.S. children five years of age or under. Early-Stage Pipeline: Advancing VAX-A1, a Potential Best-in-Class Vaccine Candidate Designed to Provide Universal Protection Against Disease Caused by Group A Strep, into the Clinic: In mid-2026, the Company plans to initiate a Phase 1 adult study for its most advanced preclinical program, VAX-A1, a prophylactic vaccine candidate designed to prevent disease caused by Group A Strep (Streptococcus pyogenes), with the primary objective of assessing safety and tolerability, along with a secondary objective of evaluating initial immunogenicity data, to support potential further advancement. This approach is designed to generate high-quality initial safety data and provide a foundation for evaluating next steps in the program's development. The Company intends to conduct this study in Australia, where Group A Strep has been problematic and there are experienced investigator networks with a high degree of expertise in the field. Group A Strep remains a major global cause of morbidity and mortality in adults and children and is a leading driver of antibiotic use, underscoring the significant public health burden. Equity Financing: Completed Underwritten Public Offering, Further Strengthening Balance Sheet: In February 2026, Vaxcyte completed an underwritten public offering of 12,650,000 shares of its common stock, which included the full exercise of the underwriters’ option to purchase an additional 1,650,000 shares, at a public offering price of $50.00 per share. The aggregate gross proceeds to Vaxcyte from this offering were $632.5 Million, before deducting underwriting discounts and commissions and other offering expenses payable by Vaxcyte. Commercial Manufacturing & Supply Chain: Progressed Manufacturing and Supply Chain Capabilities to Support Commercial Launch: In collaboration with Lonza, Vaxcyte completed construction of a dedicated, large-scale manufacturing facility designed to support potential global commercial manufacturing of its PCV candidates for all indications. Established North Carolina Presence Including Buildout of Custom PCV Fill-Finish Line: In January 2026, Vaxcyte announced the establishment of a dedicated local North Carolina presence, comprising full-time employees focused on chemistry, manufacturing and controls (CMC) activities as part of its commitment to expand U.S.-based fill-finish manufacturing capacity for its PCVs in North Carolina. As the Company advances its long-term domestic manufacturing strategy, it is recruiting experienced scientific and manufacturing professionals in one of the country’s most established vaccine-development hubs. In parallel, the buildout of the custom PCV fill-finish line at the North Carolina facility is well underway. Anticipated Program Milestones Vaxcyte is advancing the clinical development of its pipeline programs with several key milestones anticipated: VAX-31 Adult Indication Announce topline safety, tolerability and immunogenicity data from the OPUS-1 Phase 3 pivotal, noninferiority trial in the fourth quarter of 2026. Announce safety, tolerability and immunogenicity data from the OPUS-2 and OPUS-3 Phase 3 trials in the first half of 2027. VAX-31 Infant Indication Announce topline safety, tolerability and immunogenicity data from the VAX-31 infant Phase 2 randomized, dose-finding study from both the primary three-dose immunization series and booster dose either sequentially or together by the end of the first half of 2027. VAX-A1 Initiate Phase 1 adult clinical study in mid-2026, with the primary objective of assessing safety and tolerability. Upcoming Investor Conferences Company management will participate in fireside chats and host one-on-one meetings at the following investor conferences. A live webcast of the fireside chats will be accessible through the Investors & Media section of the Company's website at http://investors.vaxcyte.com for approximately 30 days following each conference. BofA Securities 2026 Health Care Conference, May 12-14: Fireside chat will take place live on Tuesday, May 12, at 4:40 p.m. ET / 1:40 p.m. PT. Jefferies Global Healthcare Conference, June 2-4: Fireside chat will take place live on Wednesday, June 3, at 4:20 p.m. ET / 1:20 p.m. PT. First Quarter 2026 Financial Results Cash Position: Cash, cash equivalents and investments were $2,741.2 million as of March 31, 2026, compared to $2,442.6 million as of December 31, 2025. Research & Development (R&D) Expenses: R&D expenses were $312.8 million for the three months ended March 31, 2026 as compared to $148.1 million for the same period in 2025. The increase was due primarily to higher development and product manufacturing costs associated with the Company's PCV programs, including an increase in manufacturing activities to support the potential future commercial launches, clinical trial expenses primarily related to the initiation and enrollment of the VAX-31 OPUS Phase 3 trials and higher personnel expenses related to the growth in the number of R&D employees. General & Administrative (G&A) Expenses: G&A expenses were $33.1 million for the three months ended March 31, 2026 as compared to $32.7 million for the same period in 2025. Net Loss: For the three months ended March 31, 2026, net loss was $320.6 million, compared to $140.7 million for the same period in 2025. About Vaxcyte Vaxcyte is a vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases. VAX-31, a 31-valent PCV candidate being evaluated in the OPUS Phase 3 adult clinical program and in a Phase 2 infant clinical program, is being developed for the prevention of IPD and is the broadest-spectrum PCV candidate in the clinic today. VAX-24, a 24-valent PCV candidate, is designed to cover more serotypes than any infant PCV on-market. VAX-31 and VAX-24 are designed to improve upon standard-of-care PCVs by covering the serotypes in circulation that cause a significant portion of IPD and are associated with high case-fatality rates, antibiotic resistance and meningitis, while maintaining coverage of previously circulating strains. VAX-XL, in earlier-stage development, also leverages the Company’s carrier-sparing, site-specific conjugation technology with the aim of further expanding coverage to deliver the broadest-spectrum candidate in the Company’s PCV franchise. Vaxcyte is re-engineering the way highly complex vaccines are made through XpressCF®, its 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 develop 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, and VAX-GI, a vaccine candidate designed to prevent Shigella. For more information, visit www.vaxcyte.com. Forward-Looking Statements This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements related to the potential benefits of Vaxcyte’s carrier-sparing platform and vaccine candidates, including breadth of coverage, the ability to deliver potentially best-in-class PCVs and improve upon the standard-of-care; the design, timing of initiation, progress and expected results of Vaxcyte's clinical trials and regulatory plans; the future commercialization of Vaxcyte’s PCV programs; Vaxcyte’s cash runway; and other statements that are not historical fact. The words “anticipate,” “believe,” “could,” “expect,” “intend,” “may,” “on track,” “potential,” “should,” “would” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) convey uncertainty of future events or outcomes and are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These forward-looking statements are based on Vaxcyte’s current expectations and actual results and timing of events could differ materially from those anticipated in such forward-looking statements as a result of risks and uncertainties, including, without limitation, risks related to Vaxcyte’s product development programs, including development timelines, success and timing of chemistry, manufacturing and controls and related manufacturing activities, potential delays or inability to obtain and maintain required regulatory approvals for its vaccine candidates, and the risks and uncertainties inherent with preclinical and clinical development processes; the success, cost and timing of all development activities and clinical trials; and sufficiency of cash and other funding to support Vaxcyte’s development programs and other operating expenses. These and other risks are described more fully in Vaxcyte’s filings with the Securities and Exchange Commission (SEC), including its Quarterly Report on Form 10-Q filed with the SEC on May 6, 2026 or in other documents Vaxcyte subsequently files with or furnishes to the SEC. All forward-looking statements contained in this press release speak only as of the date on which they were made and are based on management’s assumptions and estimates as of such date, and readers should not rely upon the information in this press release as current or accurate after its publication date. Vaxcyte undertakes no duty or obligation to update any forward-looking statements contained in this release as a result of new information, future events or changes in its expectations. Readers should not rely upon the information in this press release as current or accurate after its publication date. Contacts: Patrick Ryan, Executive Director, Corporate Affairs Vaxcyte, Inc. 415-606-5135 [email protected] Jeff Macdonald, Executive Director, Investor Relations Vaxcyte, Inc. 917-371-094 [email protected] _____________________________ (1) Amounts include stock-based compensation expense as follows: _____________________________ 1 Pneumococcal-naïve is defined as having no known prior history of IPD or pneumococcal pneumonia, or receipt of any licensed or investigational pneumococcal vaccine. 2 Lower bound of the 2-sided 95% confidence interval of the OPA geometric mean ratio is greater than 0.5. 3 Lower bound of the 2-sided 95% confidence interval of the difference in the proportions of participants with a ≥4-fold increase from Day 1 to Month 1 is greater than 10%, and lower bound of the 2-sided 95% confidence interval of the OPA geometric mean ratio is greater than 2.0. 4 Lower bound of the 2-sided 95% confidence interval of the OPA geometric mean ratio is greater than 1.0.

This article first appeared on GuruFocus. Release Date: February 24, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Vaxcyte Inc (NASDAQ:PCVX) reported unprecedented results from their phase 2 study in adults, indicating that VAX 31 may offer substantial improvement over existing pneumococcal vaccines. The company has initiated multiple phase 3 trials, including Opus 1, Opus 2, and Opus 3, to further evaluate the safety, tolerability, and immunogenicity of VAX 31. Vaxcyte Inc (NASDAQ:PCVX) completed the construction of a dedicated large-scale manufacturing facility on time and on budget, designed to support global commercial demand. The company strengthened its financial position with a successful public equity offering, raising approximately $600.2 million, providing a cash runway through at least the end of 2028. Vaxcyte Inc (NASDAQ:PCVX) resumed development of their Group A strep vaccine candidate, VAX A1, with plans to initiate a phase 1 study in adults this year. Despite progress, gaps in serotype coverage persist in current vaccines, highlighting the ongoing challenge of achieving broader spectrum protection. The company anticipates increased expenses in 2026, particularly within R&D, driven by manufacturing readiness and clinical trial expansions. There is a risk of not achieving perfection in serotype comparisons, as acknowledged by the FDA, which could impact the approval process. The competitive landscape includes other companies like GSK and Pfizer, which are also developing broader spectrum pneumococcal vaccines. The company faces challenges in demonstrating the ability to improve immune responses in previously vaccinated adults, which is crucial for obtaining a catch-up recommendation. Warning! GuruFocus has detected 3 Warning Signs with PCVX. Is PCVX fairly valued? Test your thesis with our free DCF calculator. Q: How is the Opus 1 study powered to show statistical non-inferiority against each competitor independently, and what remains to be discussed regarding the manufacturing consistency study? A: The Opus 1 study was designed in consultation with the FDA, and we have high confidence in our ability to show non-inferiority, especially against Prevnar 20, due to prior head-to-head studies. For serotypes common to all vaccines, non-inferiority needs to be shown to one comparator. The manufacturing consistency study is progressing well, with constructive discussions with the FDA, and is expected to conclude in conjunction with our BLA timing. Grant Pickering, CEO Q: What do you need to show versus PCV 21 for a catch-up recommendation in the adult market, and how confident are you in the new dosing regimen for the VAX 31 infant study? A: For a catch-up recommendation, we need to demonstrate improved responses to previously vaccinated serotypes and robust immunogenicity for incremental serotypes. In the infant study, we are confident that the new dosing regimen will show expanded coverage, as seen in previous studies, and aim to recover as many serotypes as possible. Grant Pickering, CEO Q: What are the plans for the Group A strep vaccine candidate, and is there a standardized measure for immunogenicity? A: We plan to start with a safety assessment in adults, looking at immunogenicity in both serum and saliva. There is no correlative protection, but we can conduct a small proof-of-concept study in children due to the ubiquity of strep throat. Jim Wassel, COO Q: How are you preparing for the pre-commercialization of VAX 31, and what are the plans for post-marketing studies? A: We are scaling up our organization and engaging with policymakers. Post-marketing studies will follow a test-negative design, similar to those agreed upon for current standard vaccines, to monitor pneumonia cases and confirm disease amelioration. Grant Pickering, CEO Q: What are the key developments you are monitoring in the PCV competitive landscape, and how do you plan to maintain your lead? A: We are aware of GSK's phase 1 studies and Pfizer's 25-valent vaccine in phase 2. Our 31-valent vaccine is ahead in development, and we are focused on maintaining our lead through robust clinical data and strategic planning. Grant Pickering, CEO For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Comprehensive VAX-31 Adult Phase 3 Clinical Program, Finalized in Consultation and Alignment with FDA, Advances with Three Phase 3 Studies Underway to Support Planned BLA Submission Topline Safety, Tolerability and Immunogenicity Data from OPUS-1 Expected in Fourth Quarter of 2026; OPUS-2 and OPUS-3 Results Expected in First Half of 2027 Enrollment Completed in VAX-31 Infant Phase 2 Dose-Finding Study; Topline Safety, Tolerability and Immunogenicity Data from Primary Immunization Series and Booster Dose Expected Either Sequentially or Together by End of First Half of 2027 Company Advancing Early-Stage Pipeline, Expects to Initiate Phase 1 Adult Clinical Study for VAX-A1, a Vaccine Candidate to Prevent Group A Strep, in 2026 Company Advances Global and U.S. Manufacturing Capabilities to Support Commercialization of Pneumococcal Conjugate Vaccines with Completion of Dedicated Lonza Facility and Initiation of North Carolina Fill-Finish Line Buildout Approximately $2.4 Billion in Cash, Cash Equivalents and Investments as of December 31, 2025; Excludes Approximately $600.2 Million in Net Proceeds from February 2026 Equity Offering Company to Host Webcast/Conference Call Today at 4:30 p.m. ET / 1:30 p.m. PT SAN CARLOS, Calif., Feb. 24, 2026 (GLOBE NEWSWIRE) -- Vaxcyte, Inc. (Nasdaq: PCVX), a clinical-stage vaccine innovation company, today announced financial results for the fourth quarter and full year ended December 31, 2025, and provided a business update. “In 2025, we made meaningful progress across clinical development, regulatory engagement and commercial manufacturing readiness as we advanced our broad-spectrum pneumococcal conjugate vaccine (PCV) franchise,” said Grant Pickering, Chief Executive Officer and Co-Founder of Vaxcyte. “For the VAX-31 adult program, we initiated a comprehensive Phase 3 clinical program finalized in consultation and alignment with the U.S. Food and Drug Administration (FDA) to support a planned Biologics License Application (BLA) submission. Through this program, which is enrolling subjects in the OPUS-1, OPUS-2 and OPUS-3 trials, we are aiming to expand the breadth of disease and serotype coverage while ensuring immunogenicity levels remain high to support durable protection. Based on the strength of the unprecedented results from our VAX-31 Phase 1/2 study in adults and our carrier-sparing platform, we believe we are uniquely positioned to set a new standard by which future adult pneumococcal vaccines will be measured. In parallel, we completed enrollment in the VAX-31 infant Phase 2 dose-finding study, which includes higher doses than tested previously that are designed to elicit even stronger immune responses in infants. Together, the growing body of data from both the adult and infant programs reinforces our conviction that VAX-31 has a potential best-in-class profile.” “Earlier this year, we completed an equity financing that further strengthened our balance sheet and extended our cash runway,” said Andrew Guggenhime, President and Chief Financial Officer of Vaxcyte. "With $2.4 billion in cash, cash equivalents and investments at year-end, plus the approximately $600 million in net proceeds from the recent equity financing, we believe we are well positioned to execute on our planned clinical, manufacturing and commercial readiness milestones.” Key 2025 and 2026 to Date Highlights PCV Franchise Adult Indication: Advanced Comprehensive VAX-31 Phase 3 Adult Clinical Program to Support Planned BLA Submission: The three ongoing VAX-31 Phase 3 clinical trials, finalized in consultation and alignment with the FDA, are intended to generate a broad and robust safety, tolerability and immunogenicity dataset. Across the ongoing trials, approximately 6,000 adults are expected to be enrolled in total, with approximately 3,400 participants expected to receive VAX-31. The Company is also planning a manufacturing consistency study (e.g., a lot-to-lot study) as the final Phase 3 study. Initiated OPUS-1, the Pivotal Phase 3 Noninferiority Trial: In December 2025, the Company dosed the first participants in the OPUS-1 trial evaluating VAX-31 for the prevention of invasive pneumococcal disease (IPD) and pneumonia in adults. This trial is evaluating the safety, tolerability and immune responses of VAX-31 in approximately 3,560 adults aged 50 and older through direct, head-to-head comparisons with both Capvaxive® (PCV21) and Prevnar 20® (PCV20), the current standard-of-care PCVs, with the objective of establishing a best-in-class profile for VAX-31. The trial is also evaluating the safety, tolerability and immune responses of VAX-31 in approximately 440 adults aged 18-49. OPUS-1 is being conducted at approximately 50 sites in the United States. Initiated OPUS-2 and OPUS-3 Phase 3 Trials in Key Adult Populations: In January 2026, the Company dosed the first participants in OPUS-2, a Phase 3 descriptive study designed to evaluate the safety, tolerability and immunogenicity of VAX-31 when administered concomitantly with, or one month following, a licensed, high-dose seasonal influenza vaccine in approximately 1,300 pneumococcal-naïve1 adults aged 50 years and older. OPUS-2 is being conducted at approximately 25 sites in the United States. In February 2026, the Company dosed the first participants in OPUS-3, a Phase 3 descriptive study evaluating the safety, tolerability and immunogenicity of a single dose of VAX-31 in approximately 720 adults aged 50 years and older who have previously received lower-valency pneumococcal vaccines. OPUS-3 is being conducted at approximately 30 sites in the United States. Expanded VAX-31 Adult Breakthrough Therapy Designation to Include Prevention of Pneumonia: In May 2025, the FDA expanded the adult Breakthrough Therapy designation for VAX-31 to include the prevention of pneumonia caused by Streptococcus pneumoniae, in addition to the prevention of IPD, based on the positive topline results from the VAX-31 adult Phase 1/2 study. Introduced Development of VAX-XL, the Company’s Third-Generation PCV Designed to Further Expand Disease and Serotype Coverage: The Company continues to advance its broader PCV franchise with development of VAX-XL. This vaccine candidate is in early-stage development, and leverages the Company’s carrier-sparing, site-specific conjugation technology with the aim of further expanding coverage to deliver the broadest-spectrum candidate in the Company’s PCV franchise. PCV Franchise Infant Indication: Announced Positive VAX-24 Infant Phase 2 Study Results that Informed Advancement of Modified VAX-31 Infant Phase 2 Dose-Finding Study with Inclusion of Optimized Dose: Vaxcyte is advancing the clinical development of VAX-31 in infants through a randomized Phase 2 dose-finding study designed to evaluate the safety, tolerability and immunogenicity of VAX-31 compared to PCV20 in healthy infants. The study includes a three-dose primary immunization series administered at two, four and six months of age, followed by a booster dose at 12-15 months of age, and is intended to inform dose selection for future pediatric development. The final positive data from the VAX-24 infant Phase 2 dose-finding study further validated the Company’s rationale for exploring higher doses in the ongoing VAX-31 infant Phase 2 study. Announced Positive VAX-24 Infant Phase 2 Data: In March 2025, the Company announced positive interim data from the VAX-24 infant Phase 2 dose-finding study, and in November 2025 shared final safety, tolerability and immunogenicity results that were consistent with the interim findings. The totality of data from this study supported the Company’s strategy to evaluate higher doses in the ongoing VAX-31 infant Phase 2 program. Modified VAX-31 Phase 2 Study to Include Optimized Dose: In August 2025, the Company modified the ongoing VAX-31 infant Phase 2 study to include an Optimized Dose, with the majority of serotypes dosed at 4.4 mcg and the balance dosed at 3.3 mcg. Both the Middle Dose and High Dose arms continued as planned in the study, while the Low Dose arm was discontinued. Completed Enrollment in VAX-31 Infant Phase 2 Study: In January 2026, the Company announced the completion of enrollment in the VAX-31 infant Phase 2 dose-finding study, with 900 healthy infants dosed. With enrollment complete, all participants have received at least their first dose in the primary immunization series. Early-Stage Pipeline: Advancing VAX-A1, a Vaccine Candidate Designed to Prevent Disease Caused by Group A Strep, into the Clinic: In 2026, the Company plans to initiate a Phase 1 adult study for its most advanced preclinical program, VAX-A1, a prophylactic vaccine candidate designed to prevent disease caused by Group A Strep, with the primary objective of assessing safety and tolerability. This approach is designed to generate high-quality initial safety data and provide a foundation for evaluating next steps in the program's development. Group A Strep remains a major global cause of morbidity and mortality in adults and children and is a leading driver of antibiotic use, underscoring the significant public health burden. The Company intends to conduct this study in Australia, where Group Strep A has been problematic and there are experienced investigator networks with a high degree of expertise in the field. Commercial Manufacturing & Supply Chain: Progressed Manufacturing and Supply Chain Capabilities to Support Commercial Launch: The Company continued to make progress on its manufacturing and supply chain capabilities. In collaboration with Lonza, Vaxcyte completed construction of a dedicated, large-scale manufacturing facility designed to support potential global commercial manufacturing of its PCV candidates throughout the developed world for all indications. In addition, the buildout of a high-volume, custom fill-finish line in North Carolina has been initiated as part of the Company's previously announced long-term commitment of up to $1 billion in U.S. manufacturing and services. Equity Financing: Completed Underwritten Public Offering, Further Strengthening Balance Sheet: In February 2026, Vaxcyte completed an underwritten public offering of 12,650,000 shares of its common stock, which included the full exercise of the underwriters’ option to purchase an additional 1,650,000 shares, at a public offering price of $50.00 per share. The aggregate gross proceeds to Vaxcyte from this offering were $632.5 million, before deducting underwriting discounts and commissions and other offering expenses payable by Vaxcyte. Executive Leadership Team and Board of Directors Appointments: Added Seasoned Leaders to Board of Directors and Executive Team: Vaxcyte continued to strengthen its Board of Directors and leadership team with highly regarded industry leaders to further support the advancement of its late-stage programs and preparations for potential commercialization. Dr. Olivier Brandicourt, Board of Directors: In May 2025, the Company appointed Dr. Olivier Brandicourt to its Board of Directors. Dr. Brandicourt is a veteran biopharmaceutical executive with extensive experience in global vaccine commercial strategy and execution, including prior service as Chief Executive Officer of Sanofi S.A. and Bayer HealthCare AG. Chris Griffith, Chief Business and Strategy Officer: In July 2025, Chris Griffith joined the Company as Chief Business and Strategy Officer. He brings more than 20 years of experience across corporate and business development, portfolio strategy and operations. Mike Mullette, Chief Commercial Officer: In October 2025, Mike Mullette joined the Company as Chief Commercial Officer. He brings more than 20 years of global experience in vaccines and biopharmaceuticals and is leading planning and preparations for the potential global commercialization of the Company’s PCV programs. Anticipated Program Milestones Vaxcyte is advancing the clinical development of its pipeline programs with several key milestones anticipated: VAX-31 Adult Indication Announce topline safety, tolerability and immunogenicity data from the OPUS-1 Phase 3 pivotal, noninferiority trial in the fourth quarter of 2026. Announce safety, tolerability and immunogenicity data from the OPUS-2 and OPUS-3 Phase 3 trials in the first half of 2027. VAX-31 Infant Indication Announce topline safety, tolerability and immunogenicity data from the VAX-31 infant Phase 2 randomized, dose-finding study from both the primary three-dose immunization series and booster dose either sequentially or together by the end of the first half of 2027. VAX-A1 Initiate Phase 1 adult clinical study in 2026, with the primary objective of assessing safety and tolerability. Upcoming Investor Conferences Company management will participate in fireside chats and host one-on-one meetings at the following investor conferences. A live webcast of the fireside chats will be accessible through the Investors & Media section of the Company's website at http://investors.vaxcyte.com for approximately 30 days following each conference. Cowen 46th Annual Health Care Conference, March 2-4: Fireside chat will take place live on Tuesday, March 3, at 1:10 p.m. ET / 10:10 a.m. PT. Leerink Global Healthcare Conference, March 8-11: Fireside chat will take place live on Monday, March 9, at 1:00 p.m. ET / 10:00 a.m. PT. Fourth Quarter and Full Year 2025 Financial Results Cash Position: Cash, cash equivalents and investments were $2,442.6 million as of December 31, 2025, compared to $3,134.7 million as of December 31, 2024. Research & Development (R&D) Expenses: R&D expenses were $242.1 million for the three months ended December 31, 2025 and $794.3 million for the full year 2025 as compared to $133.6 million and $476.6 million, respectively, for the same periods in 2024. The increase for the year ended December 31, 2025 was due primarily to increased development and manufacturing activities in connection with the adult and infant PCV programs, including to support the potential future commercial launches, as well as an increase in personnel expenses related to the growth in R&D employees. General & Administrative (G&A) Expenses: G&A expenses were $32.3 million for the three months ended December 31, 2025 and $129.4 million for the full year 2025 as compared to $28.5 million and $92.9 million, respectively, for the same periods in 2024. The increase for the year ended December 31, 2025 was due primarily to higher personnel expenses related to the growth in G&A employees. Net Loss: For the three months and year ended December 31, 2025, net loss was $246.5 million and $766.6 million, respectively, compared to $137.1 million and $463.9 million for the same periods in 2024. Commercial Manufacturing Facility: In the fourth quarter of 2025, Vaxcyte incurred an additional $21.8 million in capital and facility buildout expenditures related to the construction of the dedicated manufacturing facility at Lonza intended to support the potential global commercialization of the Company’s PCV programs. As of December 31, 2025, Vaxcyte had incurred $335.4 million in total capital and facility buildout expenditures that were reflected on the Company’s balance sheet as of that date. The buildout was completed in the first quarter of 2026 within the original projected budget of up to $350 million. Conference Call and Webcast Vaxcyte will host a conference call and webcast to discuss this announcement today, February 24, 2026, at 4:30 p.m. ET / 1:30 p.m. PT. To participate in the conference call, please dial 800-445-7795 (domestic) or 785-424-1699 (international) and refer to conference ID PCVXQ425. A live webcast of the conference call will be available in the Investors & Media section of the Company’s website at www.vaxcyte.com. After the live webcast, the event will remain archived on Vaxcyte’s website for 30 days. About Vaxcyte Vaxcyte is a vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases. VAX-31, a 31-valent PCV candidate being evaluated in a Phase 3 adult clinical program and in a Phase 2 infant clinical program, is being developed for the prevention of IPD and is the broadest-spectrum PCV candidate in the clinic today. VAX-24, a 24-valent PCV candidate, is designed to cover more serotypes than any infant PCV on-market. VAX-31 and VAX-24 are designed to improve upon standard-of-care PCVs by covering the serotypes in circulation that cause a significant portion of IPD and are associated with high case-fatality rates, antibiotic resistance and meningitis, while maintaining coverage of previously circulating strains. VAX-XL, in earlier-stage development, also leverages the Company’s carrier-sparing, site-specific conjugation technology with the aim of further expanding coverage to deliver the broadest-spectrum candidate in the Company’s PCV franchise. Vaxcyte is re-engineering the way highly complex vaccines are made through XpressCF®, its 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 develop 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, and VAX-GI, a vaccine candidate designed to prevent Shigella. For more information, visit www.vaxcyte.com. Forward-Looking Statements This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements related to the potential benefits of Vaxcyte’s carrier-sparing platform and PCV candidates, including breadth of coverage, the ability to deliver potentially best-in-class PCVs and improve upon the standard-of-care; the design, timing of initiation, progress and expected results of Vaxcyte's clinical trials and regulatory plans; the future commercialization of Vaxcyte’s PCV programs; Vaxcyte’s cash runway; and other statements that are not historical fact. The words “anticipate,” “believe,” “could,” “expect,” “intend,” “may,” “on track,” “potential,” “should,” “would” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) convey uncertainty of future events or outcomes and are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These forward-looking statements are based on Vaxcyte’s current expectations and actual results and timing of events could differ materially from those anticipated in such forward-looking statements as a result of risks and uncertainties, including, without limitation, risks related to Vaxcyte’s product development programs, including development timelines, success and timing of chemistry, manufacturing and controls and related manufacturing activities, potential delays or inability to obtain and maintain required regulatory approvals for its vaccine candidates, and the risks and uncertainties inherent with preclinical and clinical development processes; the success, cost and timing of all development activities and clinical trials; and sufficiency of cash and other funding to support Vaxcyte’s development programs and other operating expenses. These and other risks are described more fully in Vaxcyte’s filings with the Securities and Exchange Commission (SEC), including its Annual Report on Form 10-K filed with the SEC on February 24, 2026 or in other documents Vaxcyte subsequently files with or furnishes to the SEC. All forward-looking statements contained in this press release speak only as of the date on which they were made and are based on management’s assumptions and estimates as of such date, and readers should not rely upon the information in this press release as current or accurate after its publication date. Vaxcyte undertakes no duty or obligation to update any forward-looking statements contained in this release as a result of new information, future events or changes in its expectations. Readers should not rely upon the information in this press release as current or accurate after its publication date. Contacts: Patrick Ryan, Executive Director, Corporate Affairs Vaxcyte, Inc. 415-606-5135 [email protected] Jeff Macdonald, Executive Director, Investor Relations Vaxcyte, Inc. 917-371-094 [email protected] ___________________________________________ 1 Pneumococcal-naïve is defined as having no known prior history of IPD, pneumococcal pneumonia, or receipt of any licensed or investigational pneumococcal vaccine.

VAX-31 OPUS Phase 3 program: OPUS-1/2/3 are designed to support a BLA with OPUS-1 top-line safety/immunogenicity data due in Q4 2026 and OPUS-2/3 readouts in the first half of 2027, targeting ~6,000 adult enrollees (≈3,400 to receive VAX-31) and head-to-head non-inferiority comparisons versus Prevnar 20 and PCV21. Financial and manufacturing position: Vaxcyte finished 2025 with $2.4 billion and raised ~$600.2 million after year-end, giving cash runway “at least the end of 2028,” while investing up to $1 billion in U.S. manufacturing and preparing for commercial launch amid expected higher 2026 R&D and manufacturing expenses. Pipeline and infant program updates: The company plans to restart its Group A Strep candidate VAX-A1 with a Phase 1 adult trial in 2026, and has modified the VAX-31 infant Phase 2 (900 infants dosed) to test an optimized higher-dose arm with top-line data expected by the first half of 2027 and an unblinding decision possible by mid-2026. Interested in Vaxcyte, Inc.? Here are five stocks we like better. MarketBeat Week in Review – 4/17 - 4/21 Vaxcyte (NASDAQ:PCVX) executives used the company’s fourth-quarter and full-year 2025 earnings call to highlight progress in late-stage development of its pneumococcal conjugate vaccine (PCV) franchise, expand on plans to restart development of its Group A Strep program, and outline a strengthened balance sheet following a recent equity raise. Chief Executive Officer Grant Pickering said pneumococcal disease continues to cause substantial morbidity and mortality globally, and argued that “gaps in serotype coverage persist” despite existing vaccines. He pointed to “accelerating growth in the adult PCV market,” driven by expanded U.S. recommendations and growing international adoption, and said momentum in the category reinforces demand for a broader-coverage vaccine while maintaining strong immune responses. → Hinge Health’s AI Moat Might Be Its Patient Movement Data Still 50% Upside To Go, Wall Street Is Getting Vaxcyte Right Pickering referenced “unprecedented results” from a Phase 2 adult study of VAX-31 and said the company believes it is positioned to “set a new standard” in adult pneumococcal vaccination as the OPUS Phase 3 program advances. Executive Vice President and Chief Operating Officer Jim Wassil said the Phase 3 OPUS program was finalized “in consultation and alignment with the FDA” and is intended to support a planned biologics license application (BLA). The OPUS studies are designed to generate a broad safety, tolerability, and immunogenicity data set across adult populations and real-world vaccination scenarios. OPUS-1: A pivotal non-inferiority trial in adults aged 50 and older, comparing VAX-31 head-to-head versus Prevnar 20 (PCV20) and Capvaxive/“Quadaxix” (PCV21). Management said top-line safety, tolerability, and immunogenicity data are expected in Q4 2026. OPUS-2: A Phase 3 study evaluating VAX-31 when administered concurrently with, or one month after, a licensed high-dose seasonal influenza vaccine. Management said readout is expected in the first half of 2027. OPUS-3: A Phase 3 study in adults previously vaccinated with lower-valency pneumococcal vaccines, intended to evaluate safety and immune responses and potentially support a “catch-up” recommendation. Management also guided to a first-half 2027 readout. → Microsoft Is Sliding—An Insider Buy and Oversold Signals Are Changing the Setup Why Investors Are Suddenly Excited About Vaxcyte Wassil said OPUS-1, -2, and -3, along with a planned manufacturing consistency study, are designed to support the BLA. Across the three trials, the company expects to enroll approximately 6,000 adults, with about 3,400 receiving VAX-31. In response to investor questions on OPUS-1 powering and statistical requirements, Pickering said the pivotal trial was “locked down” with the FDA and that Vaxcyte has strong data to inform powering versus PCV20 from prior head-to-head work. For the 10 serotypes common to VAX-31, PCV20, and PCV21, he said the analysis plan requires Vaxcyte to demonstrate non-inferiority to “one or the other” comparator to declare success. He also emphasized that regulators evaluate vaccines based on the “totality” of the data package and public health impact, and said the company believes it has “headroom” given the incremental serotype coverage. → 3 Major Buybacks Just Dropped—Here’s the Signal Investors See Asked specifically about serotype 3, Pickering described it as a persistent outlier in the category and said it has not proven to be a meaningful differentiator among marketed vaccines because none have generated antibody responses seen as sufficient to control it. He added that Vaxcyte’s serotype 3 responses were better than PCV20 in its earlier adult and infant studies, but said the company does not expect serotype 3 to be a competitive differentiator. Management also addressed post-marketing expectations, stating the company’s approach is consistent with agreements used for currently marketed PCVs, including a test-negative design surveillance approach used to monitor pneumonia cases in the environment. Pickering said Vaxcyte reported final data from the VAX-24 Phase 2 dose-finding study in infants in November, and described the results as consistent with positive interim findings. He said the data provided insights into immune responses, concomitant administration with other vaccines, and dose responsiveness. Wassil said those learnings led Vaxcyte to modify its ongoing VAX-31 infant Phase 2 study to include an optimized dose arm evaluating higher doses. Enrollment is complete, with 900 infants dosed. The company expects to announce top-line safety, tolerability, and immunogenicity data for both the primary three-dose series and booster dose “either sequentially or together” by the end of the first half of 2027. Chief Financial Officer Andrew Guggenhime said the company is evaluating whether unblinding and disclosing the primary series (PD3) data earlier could provide operating benefits—such as enabling earlier FDA engagement for an end-of-Phase 2 meeting or allowing Phase 3 initiation sooner. Vaxcyte expects an update on its unblinding and disclosure plans by mid-2026. On manufacturing, Pickering said Vaxcyte completed construction of a dedicated large-scale manufacturing facility “on time and on budget,” designed to support global commercial demand in developed markets. He also said construction is underway for a high-volume, custom fill-finish production line in North Carolina as part of a long-term investment of up to $1 billion in U.S. manufacturing and services. Commercially, Pickering said the company has begun scaling the organization, including hiring its first Chief Commercial Officer, Mike Miletich, and starting launch planning. During Q&A, Miletich said the company is seeing early signals in the 50–64 age segment following the expanded U.S. recommendation, while noting that immunizations in that group may have been lower in the year due to lower influenza vaccination rates in Q4. He also said Capvaxive’s market share gains support the dynamic of the market shifting toward higher-valency vaccines, and pointed to increasing adult vaccination adoption internationally in Europe, Japan, and Canada. Financially, Guggenhime said Vaxcyte ended 2025 with $2.4 billion in cash, cash equivalents, and investments. After year-end, the company completed a public equity offering generating approximately $600.2 million in net proceeds. Including those proceeds, he said Vaxcyte expects cash runway to “at least the end of 2028.” He also forecast that 2026 total expenses—particularly R&D—will increase meaningfully versus 2025, driven by manufacturing spend to support commercial readiness (including building VAX-31 commercial supply ahead of a potential launch) and higher clinical spending from a greater number and size of trials. Guggenhime added that capitalized costs are expected to trend down in 2026 because the dedicated manufacturing facility build-out is complete and related costs will shift from capitalized to expensed. Beyond PCV, management said the company will resume development of its most advanced preclinical non-PCV program, VAX-A1, a Group A Strep vaccine candidate. Wassil said Vaxcyte expects to initiate a Phase 1 adult study in 2026, focused primarily on safety and tolerability, and plans to conduct the study in Australia. He said the trial will also assess immunogenicity (including IgA and IgG in serum and saliva), but noted there is “no correlate of protection.” He also outlined a development concept that could include moving into toddlers and pursuing a smaller proof-of-concept study given the ubiquity of strep throat in children. Guggenhime said the earlier decision to pause pipeline programs—including VAX-A1—was driven principally by financial considerations, and that the February financing helped enable the company to restart the program while maintaining resources to execute PCV milestones. Vaxcyte, Inc (NASDAQ: PCVX) is a clinical-stage biotechnology company focused on developing a new generation of preventive vaccines aimed at combating serious bacterial diseases. Headquartered in San Carlos, California, Vaxcyte leverages proprietary conjugation technologies to design and manufacture multivalent vaccines targeting pathogens for which there remain significant unmet medical needs. The company's platform is intended to streamline the production of conjugate vaccines by improving antigen presentation and broadening strain coverage compared with conventional approaches. Vaxcyte's lead candidate, VAX-24, is a 24-valent pneumococcal conjugate vaccine designed to protect against 24 serotypes of Streptococcus pneumoniae. The article "Vaxcyte Q4 Earnings Call Highlights" was originally published by MarketBeat.

Management attributes the VAX-31 opportunity to persistent gaps in serotype coverage despite decades of vaccination, positioning their 31-valent candidate to protect against both historical and currently circulating strains. The adult PCV market is experiencing accelerating growth driven by expanded U.S. age recommendations (50+) and increasing international adoption, reinforcing the demand for broader spectrum protection. Operational focus has shifted toward establishing a 'totality of data' framework for VAX-31, where the goal is to demonstrate superior public health impact rather than perfection on every individual serotype comparison. The company completed construction of a dedicated large-scale manufacturing facility on time and budget, a critical step in transitioning from a clinical-stage entity to a global commercial enterprise. Strategic organizational scaling is underway, marked by the appointment of the first Chief Commercial Officer and the initiation of formal launch planning activities. Vaxcyte resumed development of VAX-A1 (Group A Strep) after a prior pause, citing a strengthened financial position and the high unmet need for a preventative approach to a disease causing 600,000 annual deaths. Top-line safety and immunogenicity data from the pivotal OPUS-1 adult Phase III trial are expected in the fourth quarter of 2025. Readouts for the OPUS-2 (concomitant flu) and OPUS-3 (prior vaccination) trials are projected for the first half of 2027 to support a robust BLA submission. Infant VAX-31 Phase II data for both the primary series and booster dose are expected by the end of the first half of 2027, with an update on unblinding plans due mid-2025. R&D expenses are expected to increase meaningfully in 2026 to support commercial supply buildup and the expanded scale of Phase III clinical trials. Cash runway is projected to extend at least through the end of 2028, providing the financial flexibility to reach multiple regulatory and manufacturing milestones. Management noted that while regulators do not require perfection on every serotype, they believe VAX-31 has the headroom to miss on a handful of individual serotypes without risking licensure or its best-in-class profile. The transition of manufacturing costs from capitalized to expensed will occur in 2026 following the completion of the Lonza facility build-out. A long-term investment of up to $1 billion in U.S. manufacturing and services is underway, including a custom fill-finish line in North Carolina to ensure supply chain resilience. The Group A Strep program faces development risk as there is currently no established correlative of protection, requiring proof-of-concept through clinical illness monitoring. Our analysts just identified a stock with the potential to be the next Nvidia. Tell us how you invest and we'll show you why it's our #1 pick. Tap here. Management confirmed high confidence in noninferiority against Prevnar 20 based on existing head-to-head data, while comparisons to Capvaxive rely on cross-trial analysis. The FDA has explicitly stated that the vaccine does not need to be 'perfect' on every serotype; missing a handful would not risk BLA approval if the overall coverage is significantly broader. Management identified OPUS-3 as the most strategically significant secondary study because it could unlock a massive 'bolus' market of adults previously vaccinated with lower-valency products. The goal is to demonstrate that VAX-31 can boost responses to previously seen strains while providing incremental coverage without causing 'hyporesponsiveness'. Management argued that Serotype 3 has not been a differentiator for competitors because no existing vaccine reaches the protective threshold required to stop its circulation. They believe coverage of 10-11 additional serotypes is a more powerful commercial driver than marginal immunogenicity differences on a single, difficult-to-control strain. Vaxcyte is evaluating whether to unblind the primary 3-dose infant data early to accelerate end-of-Phase II meetings with the FDA and initiate Phase III sooner. A decision on whether to release data sequentially or as a full package will be announced by mid-2025. One stock. Nvidia-level potential. 30M+ investors trust Moby to find it first. Get the pick. Tap here.

SAN CARLOS, Calif., Feb. 10, 2026 (GLOBE NEWSWIRE) -- Vaxcyte, Inc. (Nasdaq: PCVX), a clinical-stage vaccine innovation company, announced today that it will report financial results for the fourth quarter and full year 2025 and provide a business update after market close on February 24, 2026. Company management will host a conference call and webcast beginning at 4:30 p.m. ET / 1:30 p.m. PT. To participate in the conference call, please dial 800-445-7795 (domestic) or 785-424-1699 (international), conference ID PCVX4Q25. A live webcast of the conference call will be available in the Investors & Media section of the Company’s website at www.vaxcyte.com. A replay of the webcast will be available for approximately 30 days following the conference call. About Vaxcyte Vaxcyte is a vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases. VAX-31, a 31-valent pneumococcal conjugate vaccine (PCV) candidate being evaluated in a Phase 3 adult clinical program and in a Phase 2 infant clinical program, is being developed for the prevention of invasive pneumococcal disease (IPD) and is the broadest-spectrum PCV candidate in the clinic today. VAX-24, a 24-valent PCV candidate, is designed to cover more serotypes than any infant PCV on-market. VAX-31 and VAX-24 are designed to improve upon standard-of-care PCVs by covering the serotypes in circulation that cause a significant portion of IPD and are associated with high case-fatality rates, antibiotic resistance and meningitis, while maintaining coverage of previously circulating strains. VAX-XL, in earlier-stage development, also leverages the Company’s carrier-sparing, site-specific conjugation technology with the aim of further expanding coverage to deliver the broadest-spectrum candidate in the Company’s PCV franchise. Vaxcyte is re-engineering the way highly complex vaccines are made through XpressCF®, its 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 develop 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, and VAX-GI, a vaccine candidate designed to prevent Shigella. For more information, visit www.vaxcyte.com. Contacts: Patrick Ryan, Executive Director, Corporate Affairs Vaxcyte, Inc. 415-606-5135 [email protected] Jeff Macdonald, Executive Director, Investor Relations Vaxcyte, Inc. 917-371-0940 [email protected]

Final Data from VAX-24 Infant Phase 2 Dose-Finding Study Consistent with Previously Reported Positive Interim Data; Provide Additional Evidence Supporting Higher VAX-31 Doses Being Evaluated in Ongoing Infant Phase 2 Study Modified VAX-31 Infant Phase 2 Dose-Finding Study Advanced to Third and Final Stage Company Expects to Initiate VAX-31 Adult Pivotal, Non-Inferiority Study in December 2025 with Topline Data in 2026 Company Establishing Fill-Finish Manufacturing in North Carolina as Key Element of Long-Term United States Commercial Supply Strategy, Aligned with Administration’s Focus on Strengthening Domestic Biomanufacturing and Representing up to $1 Billion in Manufacturing and Services Company Appoints Mike Mullette as Chief Commercial Officer as it Advances VAX-31 to Phase 3 and Potential Commercialization Company Remains Focused on Disciplined Capital Allocation and Prioritizing Resources for PCV Programs with Approximately $2.7 Billion in Cash, Cash Equivalents and Investments as of September 30, 2025, Expected to Fund Current Operating Plan into Mid-2028 SAN CARLOS, Calif., Nov. 04, 2025 (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 third quarter ended September 30, 2025, and provided a business update, including the final data from the VAX-24 infant Phase 2 dose-finding study. “We remain laser-focused on advancing the development of VAX-31, the broadest-spectrum pneumococcal conjugate vaccine (PCV) in the clinic, given its potential to substantially broaden protection against both currently circulating and historically prevalent serotypes compared to currently available PCVs,” said Grant Pickering, Chief Executive Officer and Co-founder of Vaxcyte. “For the adult indication, we expect to initiate the VAX-31 pivotal, non-inferiority study in December, with additional Phase 3 study initiations in 2026. For the infant indication, the final data from our VAX-24 infant Phase 2 dose-finding study are consistent with the previously reported positive interim data and show that VAX-24 elicited robust, dose-dependent immune responses, with little to no evidence of carrier suppression observed. These results further validate our rationale for exploring higher doses in the ongoing VAX-31 infant Phase 2 dose-finding study. Together, the growing body of data from both the adult and infant programs reinforces our conviction that VAX-31 has a potential best-in-class profile.” “We continue to take a disciplined approach to capital allocation, ending the third quarter with $2.7 billion in cash, cash equivalents and investments,” said Andrew Guggenhime, President and Chief Financial Officer of Vaxcyte. “With this strong financial position, we are advancing both the VAX-31 adult Phase 3 program and the infant Phase 2 study while investing in activities to help ensure commercial readiness. As part of that effort, our recent agreement to significantly expand our fill-finish manufacturing capacity in North Carolina further strengthens our supply chain and underscores our commitment to American biomanufacturing and innovation — all in service of our mission to deliver vaccines that protect against serious infectious diseases.” Key Third Quarter and Recent Highlights PCV Program Updates Final VAX-24 Infant Phase 2 Dose-Finding Study Data Consistent with Previously Reported Positive Interim Data: In March 2025, the Company announced topline, interim data from the VAX-24 infant Phase 2 study, a randomized, observer-blind, dose-finding two-stage clinical study evaluating the safety, tolerability and immunogenicity of VAX-24 in healthy infants that enrolled 803 participants. Today, the Company shared the final safety, tolerability, and immunogenicity results from this study that are consistent with the previously reported positive interim data and show that VAX-24 elicited robust, dose-dependent immune responses, with little to no evidence of carrier suppression observed. The totality of data from this study affirms the Company’s strategy to include the higher doses that are being evaluated in the ongoing VAX-31 infant Phase 2 dose-finding study. The final data analysis includes full 6-month safety results and complete post-dose 3 (primary immunization series) and post-dose 4 (booster dose) immunoglobulin G (IgG) and opsonophagocytic assay (OPA) results. The key immunogenicity endpoints include an assessment of immune responses for each of the VAX-24 dose levels (Low, Mid, Mixed) in comparison with Prevnar 20 (PCV20) for the 20 common and 4 unique serotypes in VAX-24. At 1-month post-dose 3 and post-dose 4, immune responses were assessed based on serotype-specific IgG seroconversion rates (IgG threshold value of ≥0.35mcg/mL). IgG Geometric Mean Ratios (GMRs) were also assessed at 1-month post-dose 3 and post-dose 4, along with other key immunogenicity endpoints, including OPA. In this study, VAX-24 was well-tolerated and demonstrated a safety profile similar to PCV20 across all doses studied. Frequently reported local and systemic reactions were generally mild-to-moderate, resolving within several days of vaccination, with no meaningful differences observed across the cohorts. No serious adverse events were considered to be related to study vaccines. Post-dose 3 and post-dose 4, all VAX-24 doses evaluated demonstrated robust IgG and OPA immunogenicity responses. Post-dose 3, all VAX-24 doses met target precedent Phase 2 non-inferiority (NI) criteria on relative seroconversion rates1 for the highest circulating serotypes2 contained in VAX-24. The Low and Mid doses met the NI criteria for 20 of 24 serotypes overall and the Mixed dose met such criteria for 19 of 24 serotypes. The Mid and Mixed doses met the target Phase 2 IgG GMR point estimate of >0.63 for 21 of 24 serotypes. Post-dose 4, all VAX-24 doses met the Company’s target Phase 2 IgG GMR point estimate of >0.6 for the three highest circulating serotypes contained in VAX-24. The Mixed dose met this target for 19 of 24 serotypes overall and the Mid dose met this target for 18 of 24 serotypes. Post-dose 4, VAX-24 elicited robust memory responses across all doses for all serotypes. Additionally, the four incremental serotypes unique to VAX-24 that provide expanded serotype coverage relative to PCV20 elicited robust immune responses and met all target criteria across all endpoints at all doses evaluated. Additional information about the study can be found at www.clinicaltrials.gov under the identifier NCT05844423. Company Advanced VAX-31 Infant Phase 2 Dose-Finding Study to Third and Final Stage: In September 2025, the Company announced that the modified VAX-31 infant Phase 2 randomized, dose-finding study had progressed to the third and final stage. VAX-31 is designed to substantially expand coverage in the pediatric population relative to today’s standard-of-care, PCV20, by adding 11 incremental serotypes with the potential to increase protection against invasive pneumococcal disease (IPD) from approximately 69% to approximately 92% of disease circulating in children under five years of age in the U.S. This study is evaluating the safety, tolerability and immunogenicity of VAX-31 compared to PCV20 in approximately 900 healthy infants. The study advanced to the final stage following protocol modifications to add a new dose arm to evaluate the VAX-31 Optimized Dose (majority of serotypes dosed at 4.4mcg and the balance dosed at 3.3mcg) and to discontinue enrollment in the Low Dose arm. The Middle and High Dose arms are continuing as planned. Additional information about the study can be found at www.clinicaltrials.gov under the identifier NCT06720038. U.S. Commercial Manufacturing Expansion Company Establishing Fill-Finish Manufacturing in North Carolina as Key Element of Long-Term United States Commercial Supply Strategy Representing Up to $1 Billion in Manufacturing and Services: In September 2025, the Company announced a new agreement with Thermo Fisher Scientific Inc. to provide custom commercial fill-finish capacity for the Company’s broad-spectrum PCVs at Thermo Fisher’s Greenville, North Carolina facility. This initiative, which includes both manufacturing and related services, represents a long-term U.S. commercial manufacturing commitment of up to $1 billion. Establishing this capacity strengthens the Company’s supply chain, supports future commercial readiness and aligns with the Administration’s focus on expanding domestic biomanufacturing infrastructure. Executive Leadership Team Appointment Company Appointed Mike Mullette as Chief Commercial Officer to Lead Commercialization Strategy and Execution: In October 2025, Mike Mullette joined Vaxcyte as Chief Commercial Officer, bringing more than 20 years of global experience in vaccines and biopharmaceuticals, including senior leadership roles at Moderna, Sanofi Pasteur and Lykos Therapeutics. As part of the Company’s strategy to prepare for future commercialization of its PCV programs, Mr. Mullette will lead the continued development and execution of global commercialization, including pre-launch planning and cross-functional readiness. He brings extensive launch leadership, having led Moderna’s first ever commercial organization in North America during the COVID-19 pandemic and launched multiple vaccines at Sanofi Pasteur across the U.S., France, Japan, Australia and Canada. Anticipated Key Milestones Vaxcyte is advancing the clinical development of its PCV programs with several anticipated key upcoming milestones: PCV Franchise Adult Indication VAX-31 Initiate the VAX-31 Phase 3 pivotal, non-inferiority study in December 2025 and announce topline safety, tolerability and immunogenicity data in 2026. Initiate remaining Phase 3 studies in 2026 and announce data from these studies in 2027. PCV Franchise Infant Indication VAX-31 Announce topline safety, tolerability and immunogenicity data for the VAX-31 infant Phase 2 randomized, dose-finding study from both the primary three-dose immunization series and booster dose either sequentially or together by the end of the first half of 2027. Upcoming Investor Conferences Company management will participate in fireside chats and host one-on-one meetings at the following investor conferences. A live webcast of the fireside chats will be accessible through the Investors & Media section of the Company's website at http://investors.vaxcyte.com for approximately 30 days following each conference. Guggenheim Healthcare Innovation Conference, November 10-12: Fireside chat will take place live on Tuesday, November 11, at 2:30 p.m. ET / 11:30 a.m. PT. Jefferies London Healthcare Conference, November 17-20: Fireside chat will take place live on Wednesday, November 19, at 2:30 p.m. GMT / 9:30 a.m. ET. Evercore ISI HealthCONx Conference, December 2-4: Fireside chat will take place live on Tuesday, December 2, at 1:20 p.m. ET / 10:20 a.m. PT. Third Quarter 2025 Financial Results Cash Position: Cash, cash equivalents and investments were $2,670.6 million as of September 30, 2025, compared to $3,134.7 million as of December 31, 2024. Research & Development (R&D) Expenses: R&D expenses were $209.9 million for the three months ended September 30, 2025 as compared to $116.9 million for the same period in 2024. The increase was due primarily to development and manufacturing activities in connection with the adult and infant PCV programs, including support for potential future commercial launches, as well as higher personnel expenses related to the growth in the number of R&D employees. General & Administrative (G&A) Expenses: G&A expenses were $32.4 million for the three months ended September 30, 2025 as compared to $23.0 million for the same period in 2024. The increase was due primarily to higher personnel expenses related to the growth in the number of G&A employees. Net Loss: For the three months ended September 30, 2025, net loss was $212.8 million, compared to $103.1 million for the same period in 2024. Commercial Manufacturing Suite: In the third quarter of 2025, Vaxcyte incurred an additional $23.0 million in capital and facility buildout expenditures related to the ongoing construction of the dedicated manufacturing suite at Lonza intended to support the potential global commercialization of the Company’s PCV programs. As of September 30, 2025, Vaxcyte had incurred $313.7 million in total capital and facility buildout expenditures that were reflected on the Company’s balance sheet as of that date. Vaxcyte continues to expect the buildout to be completed by early 2026, with total costs expected to be up to $350 million. About Vaxcyte Vaxcyte is a vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases. VAX-31, a 31-valent PCV candidate advancing to a Phase 3 adult clinical program and being evaluated in a Phase 2 infant clinical program, is being developed for the prevention of IPD and is the broadest-spectrum PCV candidate in the clinic today. VAX-24, a 24-valent PCV candidate, is designed to cover more serotypes than any infant PCV on-market. VAX-31 and VAX-24 are designed to improve upon standard-of-care PCVs by covering the serotypes in circulation that cause a significant portion of IPD and are associated with high case-fatality rates, antibiotic resistance and meningitis, while maintaining coverage of previously circulating strains. Vaxcyte is re-engineering the way highly complex vaccines are made through XpressCF®, its 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 develop 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, and VAX-GI, a vaccine candidate designed to prevent Shigella. For more information, visit www.vaxcyte.com. Forward-Looking Statements This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements related to the potential benefits of Vaxcyte’s carrier-sparing platform and PCV candidates, including breadth of coverage, the ability to deliver potentially best-in-class PCVs, improve upon the standard-of-care and substantially broaden protection against both currently circulating and historically prevalent serotypes; the process and timing of anticipated future development of Vaxcyte's vaccine candidates, including the timing and availability of data for the VAX-31 infant Phase 2 study, and the initiation of VAX-31 adult Phase 3 studies and the timing of such studies and their data readouts; the future commercialization of Vaxcyte’s PCV programs; Vaxcyte’s cash runway; and other statements that are not historical fact. The words “anticipate,” “believe,” “could,” “expect,” “intend,” “may,” “on track,” “potential,” “should,” “would” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) convey uncertainty of future events or outcomes and are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These forward-looking statements are based on Vaxcyte’s current expectations and actual results and timing of events could differ materially from those anticipated in such forward-looking statements as a result of risks and uncertainties, including, without limitation, risks related to Vaxcyte’s product development programs, including development timelines, success and timing of chemistry, manufacturing and controls and related manufacturing activities, potential delays or inability to obtain and maintain required regulatory approvals for its vaccine candidates, and the risks and uncertainties inherent with preclinical and clinical development processes; the success, cost and timing of all development activities and clinical trials; and sufficiency of cash and other funding to support Vaxcyte’s development programs and other operating expenses. These and other risks are described more fully in Vaxcyte’s filings with the Securities and Exchange Commission (SEC), including its Quarterly Report on Form 10-Q filed with the SEC on November 4, 2025 or in other documents Vaxcyte subsequently files with or furnishes to the SEC. All forward-looking statements contained in this press release speak only as of the date on which they were made and are based on management’s assumptions and estimates as of such date, and readers should not rely upon the information in this press release as current or accurate after its publication date. Vaxcyte undertakes no duty or obligation to update any forward-looking statements contained in this release as a result of new information, future events or changes in its expectations. Readers should not rely upon the information in this press release as current or accurate after its publication date. Contacts: Patrick Ryan, Executive Director, Corporate Affairs Vaxcyte, Inc. 415-606-5135 [email protected] Jeff Macdonald, Executive Director, Investor Relations Vaxcyte, Inc. 917-371-0940 [email protected] 1Lower limit of the 95% confidence interval for the difference in the proportion of participants achieving the pre-defined seroconversion rate (IgG concentration ≥0.35 mcg/mL) is > -15% for each ST (https://pmc.ncbi.nlm.nih.gov/articles/PMC7360095/). Larger Phase 3 registration studies have required that lower limit of the 95% confidence interval for the difference in the proportion of participants achieving the pre-defined seroconversion rate (IgG concentration ≥0.35 mcg/mL) be > -10% for each ST. 2Percentage of IPD caused in individuals <5 yrs of age in the U.S. in 2023 based on ABC surveillance data (https://data.cdc.gov/Public-Health-Surveillance/1998-2023-Serotype-Data-for-Invasive-Pneumococcal-/qvzb-qs6p/about_data). 3Target point estimate of 0.6 is based on the Company’s statistical analysis of precedent Phase 2 and Phase 3 studies. ___________________________________________ (1) Amounts include stock-based compensation expense as follows:

Following Interactions with FDA on VAX-31 Adult Program, Including End-of-Phase 2 Meeting, Company Finalizing Phase 3 Clinical Program to Validate VAX-31 as Potential New Standard-of-Care Adult PCV; Pivotal, Non-Inferiority Study Expected to be Initiated in Fourth Quarter of 2025 with Topline Data in 2026 FDA Provided Input on VAX-31 Adult CMC Licensure Requirements Facilitating Progression to Phase 3; Company Plans to Seek Ongoing Input as Program Advances Company Expects Multiple VAX-31 Adult Phase 3 Program Data Readouts in 2026 and 2027 to Support Biologics License Application Submission For VAX-31 Pediatric Program, Company Modifies Ongoing Infant Phase 2 Dose-Finding Study to Add a VAX-31 Optimized Dose Arm (4.4mcg/3.3mcg) and Discontinues Enrollment of Low Dose Arm; Enrollment in Modified Study Expected to Proceed by End of Third Quarter of 2025 with Topline Data from Both Primary Immunization Series and Booster Dose by End of First Half of 2027 Company Remains Focused on Disciplined Capital Allocation; Streamlining Early-Stage Pipeline to Prioritize Resources for PCV Programs and Further Extend Cash Runway Approximately $2.8 Billion in Cash, Cash Equivalents and Investments as of June 30, 2025 SAN CARLOS, Calif., Aug. 06, 2025 (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 second quarter ended June 30, 2025, and provided a business update, highlighting key clinical and regulatory progress for VAX-31, a potential best-in-class pneumococcal conjugate vaccine (PCV). “We are laser-focused on advancing the development of VAX-31 in both adults and infants, given its potential to meaningfully elevate the standard-of-care by broadening protection against invasive pneumococcal disease,” said Grant Pickering, Chief Executive Officer and Co-founder of Vaxcyte. “For the adult indication, following a series of interactions with the FDA, including an End-of-Phase 2 meeting, we are finalizing the Phase 3 program, the results of which we believe could validate the best-in-class potential of VAX-31. This work includes final-stage planning for the pivotal, non-inferiority study, which we intend to initiate in the fourth quarter of this year with topline data expected in 2026, consistent with prior readout guidance. We look forward to delivering multiple anticipated Phase 3 data readouts in 2026 and 2027 to support our potential BLA submission for the VAX-31 adult indication. For the infant indication, we have leveraged key insights from the robust VAX-24 and VAX-31 data generated to date, as well as our carrier-sparing platform, to support the evaluation of a new, Optimized dose in the ongoing VAX-31 Phase 2 dose-finding study to elicit even stronger immune responses in this population. We expect the modified study to proceed by the end of the third quarter of this year with topline data from both the primary immunogenicity series and the booster dose expected by the end of the first half of 2027. We believe the incorporation of this new, Optimized dose arm, which results in a minor extension to our prior readout timeline, best positions VAX-31 for long-term success.” “With a strong balance sheet totaling approximately $2.8 billion in cash, cash equivalents and investments as of the end of the second quarter, we remain focused on advancing VAX-31, our lead candidate and the broadest-spectrum PCV in the clinic today,” said Andrew Guggenhime, President and Chief Financial Officer of Vaxcyte. “In this dynamic macro environment, we continue to take a disciplined approach to capital allocation, directing resources to further extend our cash runway and fully support the continued progress of our PCV programs, including preparation for our planned VAX-31 adult Phase 3 program and pursuit of potential U.S. commercialization. As part of this focused strategy, among other initiatives, we are streamlining activities across our early-stage pipeline while preserving the option to advance promising programs in the future.” Key Second Quarter and Recent Highlights PCV Program Updates VAX-31 Adult Program Updates Following Interactions with U.S. Food and Drug Administration (FDA) on VAX-31 Adult Program, Including End-of-Phase 2 Meeting, Company Finalizing Phase 3 Clinical Program to Validate VAX-31 as Potential New Standard-of-Care Adult PCV to Prevent Invasive Pneumococcal Disease (IPD) and Pneumonia: Through a series of interactions with the FDA, including an End-of-Phase 2 meeting, regarding the VAX-31 adult Phase 3 clinical program, the FDA provided input on the adult commercial licensure requirements, including the approximate number of study participants in the Phase 3 program; key immunogenicity and safety endpoints for the pivotal, non-inferiority study; and a continued indication that the scale of the planned immunogenicity and safety assessments are in line with precedent requirements and will be sufficient to support potential licensure. Additionally, as part of ongoing discussions granted under the VAX-31 adult Breakthrough Therapy designation (BTD), the FDA provided input on the chemistry, manufacturing and controls (CMC) licensure requirements in support of the Company’s path to delivering a Biologics License Application (BLA) submission. The Company is incorporating the FDA’s input to finalize the Phase 3 program designed to validate VAX-31 as the potential new standard-of-care adult PCV. This includes conducting final-stage planning for the pivotal, non-inferiority study, which is expected to be initiated in the fourth quarter of this year, with topline data expected in 2026, consistent with prior readout guidance. Initiation of the remaining Phase 3 studies, which are shorter in duration than the non-inferiority study, is planned for 2025 and 2026. The VAX-31 High dose (all serotypes dosed at 3.3mcg or 4.4mcg) has been selected to advance into Phase 3. Subject to the results of the Phase 3 studies, which are expected to read out in 2026 and 2027, the Company plans to submit a BLA shortly following the completion of the last Phase 3 study. FDA Expanded VAX-31 Adult BTD to Include Prevention of Pneumonia Caused by Streptococcus Pneumoniae in Addition to IPD: In May 2025, the FDA expanded the adult BTD for VAX-31 to include the prevention of pneumonia in addition to the prevention of IPD based on the positive topline results from the VAX-31 adult Phase 1/2 study, indicating that VAX-31 may demonstrate substantial improvement over existing therapies. The BTD process is designed to expedite the development and review of drugs and biologics that are intended to treat a serious or life-threatening condition. VAX-31 Infant Program Updates Company Modified Ongoing VAX-31 Infant Phase 2 Dose-Finding Study to Add a VAX-31 Optimized Dose Designed to Elicit Even Stronger Immune Responses in Pediatric Population: The Company has modified the ongoing VAX-31 infant Phase 2 randomized, dose-finding study to add a new dose arm to evaluate a VAX-31 Optimized dose with the majority of serotypes dosed at 4.4mcg and the balance dosed at 3.3mcg. Both the Middle dose and High dose VAX-31 arms in the study will proceed, while the Company has elected to discontinue enrollment in the Low dose arm. The modified study will evaluate VAX-31 in approximately 900 participants, including the 100 participants previously enrolled in the Low dose arm. Enrollment in the modified study is expected to proceed by the end of the third quarter of this year with topline data from both the primary immunization series and the booster dose by the end of the first half of 2027. Early-Stage Pipeline Updates Streamlined Early-Stage Pipeline to Prioritize Resources for PCV Programs: As part of its continued focus on strategic capital deployment, the Company is prioritizing resources toward its PCV franchise. To this end, the Company has paused the advancement, beyond preclinical development, of VAX-A1, a prophylactic vaccine candidate designed to prevent Group A Strep infections, and VAX-GI, a vaccine candidate designed to prevent Shigella, while remaining confident in their potential and preserving the option to advance the programs in the future. Additionally, the Company has discontinued further development of VAX-PG, a therapeutic vaccine candidate designed to slow or stop the progression of periodontal disease. VAX-PG preclinical data demonstrated an acceptable safety profile but not sufficient efficacy signals to warrant further investment. Executive Leadership Team Appointment Appointed Chief Business and Strategy Officer: In July, Chris Griffith joined Vaxcyte as Chief Business and Strategy Officer. With more than 20 years of experience spanning corporate and business development, portfolio strategy and business operations, Mr. Griffith brings deep expertise to this newly expanded role. His leadership will help ensure strong cross-functional alignment and execution as the Company advances its late-stage programs and prepares for the next phase of growth. Anticipated Key PCV Program Milestones Vaxcyte is advancing the clinical development of its PCV programs with several anticipated key upcoming milestones: PCV Franchise Adult Indication VAX-31 Initiate the Phase 3 pivotal, non-inferiority study in the fourth quarter of 2025 and announce topline safety, tolerability and immunogenicity data in 2026, consistent with prior readout guidance. Initiate remaining Phase 3 studies in 2025 and 2026 and announce data from these studies in 2026 and 2027, consistent with prior guidance. PCV Franchise Infant Indication VAX-24 Announce the balance of the VAX-24 Phase 2 dose-finding study data, including final safety data, full post-dose 3 opsonophagocytic assay (OPA) data, and full post-dose 4 immunoglobulin G (IgG) and OPA data, by the end of 2025. VAX-31 Proceed with the modified Phase 2 randomized, dose-finding study by the end of the third quarter of 2025. Announce topline safety, tolerability and immunogenicity data for the Phase 2 randomized, dose-finding study from both the primary three-dose immunization series and booster dose by the end of the first half of 2027, representing a minor extension to prior readout guidance. Upcoming Investor Conferences Company management will participate in the following upcoming investor conferences. Cantor Global Healthcare Conference, September 3-5, 2025: Fireside chat will take place live on Wednesday, September 3 at 11:45 a.m. PT / 2:45 p.m. ET. The fireside chat webcast will be accessible through the Investors & Media section of the Company’s website at http://investors.vaxcyte.com for approximately 30 days. Wells Fargo Healthcare Conference, September 3-5, 2025 Second Quarter 2025 Financial Results Cash Position: Cash, cash equivalents and investments were $2,826.5 million as of June 30, 2025, compared to $3,134.7 million as of December 31, 2024. As a result of the Company’s continued focus on disciplined capital allocation and evaluation of investment priorities, including streamlining activities across the early-stage pipeline, the Company has extended its cash runway and now expects its cash, cash equivalents and investments to fund its current operating plan to mid-2028. Research & Development (R&D) Expenses: R&D expenses were $194.2 million for the three months ended June 30, 2025 as compared to $131.5 million for the same period in 2024. The increase was due primarily to development and manufacturing activities in connection with the adult and infant PCV programs, including support for potential future commercial launches, as well as higher personnel expenses related to the growth in the number of R&D employees. General & Administrative (G&A) Expenses: G&A expenses were $32.0 million for the three months ended June 30, 2025 as compared to $21.5 million for the same period in 2024. The increase was due primarily to higher personnel expenses related to the growth in the number of G&A employees. Net Loss: For the three months ended June 30, 2025, net loss was $166.6 million, compared to $128.7 million for the same period in 2024. Commercial Manufacturing Suite: In the second quarter of 2025, Vaxcyte incurred an additional $44.6 million in capital and facility buildout expenditures related to the ongoing construction of the dedicated manufacturing suite at Lonza intended to support the potential global commercialization of the Company’s PCV programs. As of June 30, 2025, Vaxcyte had incurred $290.6 million in total capital and facility buildout expenditures that were reflected on the Company’s balance sheet as of that date. Vaxcyte continues to expect the buildout to be completed by early 2026 at a total cost of approximately $300-$350 million. About Vaxcyte Vaxcyte is a vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases. VAX-31, a 31-valent PCV candidate advancing to a Phase 3 adult clinical program and being evaluated in a Phase 2 infant clinical program, is being developed for the prevention of IPD and is the broadest-spectrum PCV candidate in the clinic today. VAX-24, a 24-valent PCV candidate, is designed to cover more serotypes than any infant PCV on-market and is being evaluated in a Phase 2 infant study. VAX-31 and VAX-24 are designed to improve upon standard-of-care PCVs by covering the serotypes in circulation that cause a significant portion of IPD and are associated with high case-fatality rates, antibiotic resistance and meningitis, while maintaining coverage of previously circulating strains. Vaxcyte is re-engineering the way highly complex vaccines are made through XpressCF®, its 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 develop 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, and VAX-GI, a vaccine candidate designed to prevent Shigella. For more information, visit www.vaxcyte.com. Forward-Looking Statements This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements related to the potential benefits of Vaxcyte’s carrier-sparing platform and PCV candidates, including breadth of coverage, the ability to deliver potentially best-in-class PCVs, improve upon the standard-of-care and set a new standard for immunogenicity and disease coverage while maintaining coverage of previously circulating strains; the process and timing of anticipated future development of Vaxcyte's vaccine candidates, including the continuation of the VAX-31 infant Phase 2 dose-finding study, timing and availability of data for the VAX-24 and VAX-31 infant Phase 2 studies, and the initiation of VAX-31 adult Phase 3 studies and the timing of such studies and their data readouts and the ability of such studies to validate the best-in-class potential of VAX-31 and support a BLA submission, the timing of such BLA submission; and other statements that are not historical fact. The words “anticipate,” “believe,” “could,” “expect,” “intend,” “may,” “on track,” “potential,” “should,” “would” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) convey uncertainty of future events or outcomes and are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These forward-looking statements are based on Vaxcyte’s current expectations and actual results and timing of events could differ materially from those anticipated in such forward-looking statements as a result of risks and uncertainties, including, without limitation, risks related to Vaxcyte’s product development programs, including development timelines, success and timing of chemistry, manufacturing and controls and related manufacturing activities, potential delays or inability to obtain and maintain required regulatory approvals for its vaccine candidates, and the risks and uncertainties inherent with preclinical and clinical development processes; the success, cost and timing of all development activities and clinical trials; and sufficiency of cash and other funding to support Vaxcyte’s development programs and other operating expenses. These and other risks are described more fully in Vaxcyte’s filings with the Securities and Exchange Commission (SEC), including its Quarterly Report on Form 10-Q filed with the SEC on August 6, 2025 or in other documents Vaxcyte subsequently files with or furnishes to the SEC. All forward-looking statements contained in this press release speak only as of the date on which they were made and are based on management’s assumptions and estimates as of such date, and readers should not rely upon the information in this press release as current or accurate after its publication date. Vaxcyte undertakes no duty or obligation to update any forward-looking statements contained in this release as a result of new information, future events or changes in its expectations. Readers should not rely upon the information in this press release as current or accurate after its publication date. Contacts: Patrick Ryan, Executive Director, Corporate Affairs Vaxcyte, Inc. 415-606-5135 [email protected] Jeff Macdonald, Executive Director, Investor Relations Vaxcyte, Inc. 917-371-0940 [email protected]

-- Company Reported Positive Topline Safety, Tolerability and Immunogenicity Data from Phase 2 Dose-Finding Study of VAX-24 in Healthy Infants; Balance of Data Expected by End of 2025 -- -- Initiated Second and Final Stage of VAX-31 Infant Phase 2 Dose-Finding Study; Topline Safety, Tolerability and Immunogenicity Data from Primary Three-Dose Immunization Series Expected in Mid-2026, With Complete Booster Data Up to Nine Months Later -- -- Company Expects to Initiate VAX-31 Adult Phase 3 Pivotal, Non-Inferiority Study by Mid-2025 and Announce Topline Safety, Tolerability and Immunogenicity Data in 2026 -- -- Announced VAX-XL, Third-Generation Pneumococcal Conjugate Vaccine Candidate Designed to Further Expand Spectrum of Coverage -- -- Approximately $3.0 Billion in Cash, Cash Equivalents and Investments as of March 31, 2025 -- SAN CARLOS, Calif., May 07, 2025 (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, 2025, and provided a business update. “We continue to make meaningful progress across our pneumococcal conjugate vaccine (PCV) candidates, with each milestone bringing us closer to potentially delivering the broadest-spectrum PCVs to address the substantial invasive pneumococcal disease burden in both adults and infants,” said Grant Pickering, Chief Executive Officer and Co-founder of Vaxcyte. “For the adult indication, we expect to initiate the VAX-31 adult Phase 3 pivotal, non-inferiority study by the middle of this year with topline data expected next year. For the pediatric indication, we expect to announce the balance of the VAX-24 infant Phase 2 dose-finding study data by the end of 2025 and share topline data from the VAX-31 infant Phase 2 dose-finding study primary immunization series in mid-2026, followed by complete booster data up to nine months later. Pending the VAX-31 infant study readout, we plan to initiate a Phase 3 program with an optimized dose formulation of VAX-24 or VAX-31.” “With a strong balance sheet totaling approximately $3.0 billion in cash, cash equivalents and investments, we are well-positioned to continue advancing our PCV pipeline, which we believe has the potential to redefine the standard of protection against devastating diseases caused by Streptococcus pneumoniae,” said Andrew Guggenhime, President and Chief Financial Officer of Vaxcyte. “As we enter this next chapter of growth within a dynamic macro environment, we are evaluating our investment priorities and allocation of capital to ensure the continued strength of our balance sheet and to deliver on the promise of our PCV franchise.” Key First Quarter Highlights PCV Franchise Board of Directors Appointment Appointed Dr. Olivier Brandicourt: In May 2025, Vaxcyte appointed Dr. Olivier Brandicourt to its Board of Directors. Dr. Brandicourt is a veteran biopharmaceutical industry executive and the former Chief Executive Officer of Sanofi S.A. and Bayer HealthCare AG. He brings a wealth of expertise, with significant experience in commercial strategy and execution within the global vaccine market. Dr. Brandicourt is currently a Senior Advisor at Blackstone Life Sciences and serves on the boards of Alnylam Pharmaceuticals, Inc., AvenCell Therapeutics, Inc., BeOne Medicines Ltd. and Dewpoint Therapeutics, Inc. Anticipated Key Milestones Vaxcyte is advancing the clinical development of its PCV programs with several anticipated key upcoming milestones: PCV Franchise Adult Indication VAX-31 Following an FDA End-of-Phase 2 meeting, initiate a Phase 3 pivotal, non-inferiority study by mid-2025 and announce topline safety, tolerability and immunogenicity data in 2026. Initiate the remaining Phase 3 studies in 2025 and 2026 and announce data from these studies in 2026 and 2027. PCV Franchise Infant Indication The Company plans to initiate an infant Phase 3 program with an optimized dose formulation of VAX-24 or VAX-31, pending the VAX-31 topline Phase 2 dose-finding study readout. VAX-24 Announce the balance of the VAX-24 Phase 2 dose-finding study data, including final safety data, full post-dose 3 OPA data, and full post-dose 4 IgG and OPA data, by end of 2025. VAX-31 Announce topline safety, tolerability and immunogenicity data for the Phase 2 dose-finding study primary three-dose immunization series in mid-2026, with complete booster data up to nine months later. Upcoming May and June Investor Conferences Company management will participate in fireside chats and host one-on-one meetings at the following investor conferences. A live webcast of the fireside chats will be accessible through the Investors & Media section of the Company’s website at http://investors.vaxcyte.com for approximately 30 days following each conference. BofA Securities 2025 Health Care Conference, May 13-15, 2025: Fireside Chat will take place live on Tuesday, May 13 at 8:40 a.m. PT / 11:40 a.m. ET. Jefferies Global Healthcare Conference, June 3-5, 2025: Fireside Chat will take place live on Thursday, June 5 at 6:55 a.m. PT / 9:55 a.m. ET. Goldman Sachs 46th Annual Global Healthcare Conference, June 9-11, 2025: Fireside Chat will take place live on Tuesday, June 10 at 10:20 a.m. PT / 1:20 p.m. ET. First Quarter 2025 Financial Results Cash Position: Cash, cash equivalents and investments were $2,950.8 million as of March 31, 2025, compared to $3,134.7 million as of December 31, 2024. Research & Development (R&D) Expenses: R&D expenses were $148.1 million for the three months ended March 31, 2025 as compared to $94.6 million for the same period in 2024. The increase was due primarily to development and manufacturing activities in connection with the adult and infant PCV programs, including to support potential future commercial launches, as well as higher personnel expenses related to the growth in the number of R&D employees. General & Administrative (G&A) Expenses: G&A expenses were $32.7 million for the three months ended March 31, 2025 as compared to $19.9 million for the same period in 2024. The increase was due primarily to higher personnel expenses related to the growth in the number of G&A employees. Net Loss: For the three months ended March 31, 2025, net loss was $140.7 million, compared to $95.0 million for the same period in 2024. Commercial Manufacturing Suite: In the first quarter of 2025, Vaxcyte incurred an additional $31.7 million in capital and facility buildout expenditures related to the ongoing construction of the dedicated manufacturing suite at Lonza intended to support the potential global commercialization of the Company’s PCV programs. As of March 31, 2025, Vaxcyte had incurred $246.0 million in total capital and facility buildout expenditures that were reflected on the Company’s balance sheet as of that date. Vaxcyte continues to expect the buildout to be completed by early 2026 at a total cost of approximately $300-350 million. 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, a 31-valent PCV candidate advancing to a Phase 3 adult clinical program and currently being evaluated in a Phase 2 infant clinical program, is being developed for the prevention of 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. For more information, visit www.vaxcyte.com. Forward-Looking Statements This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements related to the potential benefits of VAX-24 and VAX-31, including breadth of coverage, the ability to deliver potentially best-in-class PCVs, improve upon the standard-of-care and set a new standard for immunogenicity and disease coverage; the process and timing of anticipated future development of Vaxcyte’s vaccine candidates, including the timing and availability of data for the VAX-24 and VAX-31 infant Phase 2 studies, the initiation of VAX-24 or VAX-31 infant Phase 3 studies, and the initiation of VAX-31 adult Phase 3 studies and the timing of such studies and their data readouts; the demand for Vaxcyte’s vaccine candidates; and other statements that are not historical fact. The words “anticipate,” “believe,” “could,” “expect,” “intend,” “may,” “on track,” “potential,” “should,” “would” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) convey uncertainty of future events or outcomes and are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These forward-looking statements are based on Vaxcyte’s current expectations and actual results and timing of events could differ materially from those anticipated in such forward-looking statements as a result of risks and uncertainties, including, without limitation, risks related to Vaxcyte’s product development programs, including development timelines, success and timing of chemistry, manufacturing and controls and related manufacturing activities, potential delays or inability to obtain and maintain required regulatory approvals for its vaccine candidates, and the risks and uncertainties inherent with preclinical and clinical development processes; the success, cost and timing of all development activities and clinical trials; and sufficiency of cash and other funding to support Vaxcyte’s development programs and other operating expenses. These and other risks are described more fully in Vaxcyte’s filings with the Securities and Exchange Commission (SEC), including its Quarterly Report on Form 10-Q filed with the SEC on May 7, 2025 or in other documents Vaxcyte subsequently files with or furnishes to the SEC. All forward-looking statements contained in this press release speak only as of the date on which they were made and are based on management’s assumptions and estimates as of such date, and readers should not rely upon the information in this press release as current or accurate after its publication date. Vaxcyte undertakes no duty or obligation to update any forward-looking statements contained in this release as a result of new information, future events or changes in its expectations. Readers should not rely upon the information in this press release as current or accurate after its publication date. (1) Lower limit of the 95% confidence interval for the difference between the proportion of participants achieving the pre-defined seroconversion rate (IgG concentration ≥0.35 mcg/mL) is > -15% for each ST (https://pmc.ncbi.nlm.nih.gov/articles/PMC7360095/). Larger Phase 3 registration studies have required that lower limit of the 95% confidence interval for the difference between the proportion of participants achieving the pre-defined seroconversion rate (IgG concentration ≥0.35 mcg/mL) is > -10% for each ST. (2) Percentage of IPD caused in individuals <5 yrs of age in the U.S. in 2023 based on ABC surveillance data (https://data.cdc.gov/Public-Health-Surveillance/1998-2023-Serotype-Data-for-Invasive-Pneumococcal-/qvzb-qs6p/about_data). (3) Target point estimate of 0.6 is based on the Company’s statistical analysis of precedent Phase 2 and Phase 3 studies. Contacts: Patrick Ryan, Executive Director, Corporate Communications Vaxcyte, Inc. 415-606-5135 [email protected] Jennifer Zibuda, Senior Director, Investor Relations Vaxcyte, Inc. 860-729-8902 [email protected]