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Vaxcyte, Inc.

For the period ended Jun 30, 2026. Filed Aug 5, 2026.

View on SEC.gov

About this filing

A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.

Jun 30, 2026 · Filed Aug 5, 2026

PCVX$63.89+3.2%Stored close · as of Nov 6, 2026

What changed in Management’s Discussion and Analysis?

Read the current filing

Previous report: 10-Q

Period ended 2026-03-31; filed 2026-05-06.

0001649094-26-000017

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

Current report: 10-Q

Period ended 2026-06-30; filed 2026-08-05.

0001649094-26-000043

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

The baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.

Compared 202 previous paragraphs and 198 current paragraphs.

164 unchanged; 26 reworded; 6 added; 8 removed; 4 previous and 2 current paragraphs rearranged.

Tables are not compared: 4 previous and 4 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.

A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.

Added paragraphs (6)

Current report

•Advanced VAX-31 Adult Phase 3 Program: 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 FDA, are designed to generate a broad and robust safety, tolerability and immunogenicity dataset. In addition, we are 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.

Current report

•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. We thank 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.

Current report

Research and development expenses increased by $73.7 million, or 37.9%, during the three months ended June 30, 2026, compared to the corresponding period in 2025. The increase was largely driven by external costs, which grew by $64.1 million primarily due to increased activities related to clinical trials and product manufacturing in connection with our PCV programs. Clinical trials-related expenses increased by $25.4 million primarily due to the activities associated with the VAX-31 OPUS-1, OPUS-2, and OPUS-3 Phase 3 studies. Product manufacturing costs increased by $23.2 million primarily driven by increased manufacturing activities to support the potential future commercial launches. Research expenses increased by $13.3 million, and other external costs increased by $1.9 million compared to the corresponding period in 2025. The increase was further driven by internal personnel-related costs, which grew by $9.6 million, primarily due to headcount growth.

Current report

General and administrative expenses increased by $2.9 million, or 9.0% during the three months ended June 30, 2026 compared to the corresponding period in 2025, which was driven primarily by an increase in internal personnel-related costs due to headcount growth.

Current report

General and administrative expenses increased by $3.3 million, or 5.1%, during the six months ended June 30, 2026 compared to the corresponding period in 2025 which was driven primarily by an increase in internal personnel-related costs due to headcount growth

Current report

In July 2026, a total of 3,946,094 shares underlying the pre-funded warrants from various underwritten public offerings were exercised to receive 3,946,020 shares of common stock, net of exercise costs.
Removed paragraphs (8)

Previous report

•Advanced VAX-31 Adult Phase 3 Program: In the first quarter of 2026, we announced several clinical milestones related to our VAX-31 adult program, which was designed in consultation and alignment with the FDA. These included:

Previous report

◦OPUS-1: In March 2026, we announced we completed enrollment of this Phase 3 pivotal, noninferiority trial comparing VAX-31 to the standard-of care PCVs, PCV20 and PCV21, with 4,049 participants dosed.

Previous report

◦OPUS-3: In February 2026, we announce the first patients had been dosed in this Phase 3 trial evaluating VAX-31 in adults who have previously received pneumococcal vaccination. In May 2026, we announced we completed enrollment of this trial with 752 participants dosed.

Previous report

•Positive VAX-31 Phase 1/2 Adult Data Published in The Lancet Infectious Disease: In March 2026, we announced the publication of positive results from the VAX-31 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 OPA and 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 OPUS Phase 3 program, met or exceeded the OPA response noninferiority criteria (lower bound of the 2-sided 95% confidence interval of the OPA GMR is greater than 0.5) for all 20 serotypes common with PCV20 and met the superiority criteria (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 GMR is greater than 2.0) 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 (GMR greater than 1.0), with seven of these serotypes achieving statistically higher immune responses compared to PCV20.

Previous report

•Completed Enrollment of VAX-31 Phase 2 Infant Study: In January 2026, we announced we completed enrollment of 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.

Previous report

•Progressed Manufacturing and Supply Chain Capabilities to Support Commercial Launch: In collaboration with Lonza, we completed construction of a dedicated, large-scale manufacturing facility designed to support potential global commercial manufacturing of its PCV candidates for all indications.

Previous report

•Established North Carolina Presence Including Buildout of Custom PCV Fill-Finish Line: In January 2026, we 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 our commitment to expand U.S.-based fill-finish manufacturing capacity for our PCVs in North Carolina. As we advance our long-term domestic manufacturing strategy, we are 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.

Previous report

General and administrative expenses increased by $0.4 million, or 1.3%, and remained relatively flat during the three months ended March 31, 2026 compared to the corresponding period in 2025.
Reworded paragraphs (26)

Previous wording

▪VAX-31 is a 31-valent, broad-spectrum, carrier-sparing investigational PCV being developed for the prevention of IPD and pneumonia. VAX-31 is the broadest-spectrum PCV in the clinic, and has the potential to provide protection against both currently circulating and historically prevalent serotypes. VAX-31 was designed to increase coverage, in a single vaccine, to approximately 95% of IPD and approximately 88% of pneumococcal pneumonia circulating in adults in the United States aged 50 and older, with the potential to provide an incremental 14-34% of coverage for IPD and an incremental 19-31% of coverage for pneumococcal pneumonia over current standard-of-care adult PCVs.

Current wording

▪VAX-31 is a 31-valent, broad-spectrum, carrier-sparing investigational PCV being developed for the prevention of IPD and pneumonia. VAX-31 is the broadest-spectrum PCV in the clinic, and has the potential to provide protection against both currently circulating and historically prevalent serotypes. VAX-31 was designed to increase coverage, in a single vaccine, to approximately 95% of IPD and approximately 88% of pneumococcal pneumonia circulating in adults in the United States aged 50 and older, with the potential to provide an incremental 13-36% broader coverage for IPD and an incremental 19-31% broader coverage for pneumococcal pneumonia over current standard-of-care adult PCVs.

Previous wording

•In December 2025, following an FDA End-of-Phase 2 meeting, we announced that the first participants were dosed in a Phase 3 pivotal, non-inferiority trial ("OPUS-1") evaluating the safety, tolerability and immune responses of VAX-31 in healthy, pneumococcal-naïve (defined as having no known prior history of IPD or pneumococcal pneumonia, or receipt of any licensed or investigational pnemococcal vaccine) adults aged 50 and older through direct, head-to-head comparisons with both PVC20 and PCV21, the current standard-of-care PCVs. In March 2026, we announced that we completed enrollment of this trial. We expect to announce topline safety, tolerability and immunogenicity data from this study in the fourth quarter of 2026.

Current wording

•In December 2025, following an FDA End-of-Phase 2 meeting, we announced that the first participants were dosed in a Phase 3 pivotal, non-inferiority trial ("OPUS-1") evaluating the safety, tolerability and immune responses of VAX-31 in healthy, pneumococcal-naïve (defined as having no known prior history of IPD or pneumococcal pneumonia, or receipt of any licensed or investigational pneumococcal vaccine) adults aged 50 and older through direct, head-to-head comparisons with both PVC20 and PCV21, the current standard-of-care PCVs. In March 2026, we announced that we completed enrollment of this trial. We expect to announce topline safety, tolerability and immunogenicity data from this study in the fourth quarter of 2026.

Previous wording

•In January 2026, we announced the initiation of an additional Phase 3 trial evaluating VAX-31 when administered concomitantly with a licensed, high-dose seasonal influenza vaccine in pneumococcal-naïve adults aged 50 years and older (“OPUS-2”). In February 2026, we announced the initiation of a separate Phase 3 study evaluating VAX-31 in adults previously vaccinated with a lower-valency pneumococcal vaccine (“OPUS-3”). In March 2026, we announced we completed enrollment of the OPUS-2 trial and in May 2026, we announced we completed enrollment of the OPUS-3 trial. We expect to report safety, tolerability and immunogenicity data from the OPUS-2 and OPUS-3 studies in the first half of 2027. We are also planning for a manufacturing consistency study (e.g., a lot-to-lot study).

Current wording

•In January 2026, we announced the initiation of an additional Phase 3 trial evaluating VAX-31 when administered concomitantly with a licensed, high-dose seasonal influenza vaccine in pneumococcal-naïve adults aged 50 years and older (“OPUS-2”). In February 2026, we announced the initiation of a separate Phase 3 study evaluating VAX-31 in adults previously vaccinated with a lower-valency pneumococcal vaccine (“OPUS-3”). In March 2026, we announced we completed enrollment of the OPUS-2 trial and in May 2026, we announced we completed enrollment of the OPUS-3 trial. We expect to report safety, tolerability and immunogenicity data from the OPUS-2 and OPUS-3 studies in the first half of 2027. We are also planning for a manufacturing consistency study (e.g., a lot-to-lot study) as the final Phase 3 study to enable the submission of the Biologics License Application (BLA).

Previous wording

▪VAX-31 is a 31-valent, broad-spectrum, carrier-sparing investigational PCV also being developed for the prevention of IPD in children. VAX-31 is the broadest-spectrum PCV in the clinic designed to cover approximately 92% of IPD in U.S. children under five years of age and approximately 96% of otitis media due to Streptococcus pneumoniae in U.S. children five years of age or under.

Current wording

▪VAX-31 is a 31-valent, broad-spectrum, carrier-sparing investigational PCV also being developed for the prevention of IPD in children. VAX-31 is the broadest-spectrum PCV in the clinic designed to cover approximately 91% of IPD in U.S. children under five years of age and approximately 96% of otitis media due to Streptococcus pneumoniae in U.S. children five years of age or under.

Previous wording

▪In December 2024, we announced that the first participants were dosed in the first stage of a Phase 2, randomized, dose-finding study of VAX-31 in infants. Stage 1 of the study evaluated the safety and tolerability of VAX-31 at three dose levels (Low, Middle and High) and compared to PCV20 in 48 infants in a dose-escalation approach. In the Low, Middle and High Doses, all serotypes were dosed at 1.1mcg, 2.2mcg and 3.3mcg, respectively, except serotypes 1, 5 and 22F, which were dosed at 1.65mcg,

Current wording

▪In December 2024, we announced that the first participants were dosed in the first stage of a Phase 2, randomized, dose-finding study of VAX-31 in infants. Stage 1 of the study evaluated the safety and tolerability of VAX-31 at three dose levels (Low, Middle and High) and compared to PCV20 in 48 infants in a dose-escalation approach. In the Low, Middle and High Doses, all serotypes were dosed at 1.1mcg, 2.2mcg and

Previous wording

3.3mcg, and 4.4mcg, respectively. Participants who received VAX-31 in Stage 1 continued the standard dosing regimen as part of Stage 2.

Current wording

3.3mcg, respectively, except serotypes 1, 5 and 22F, which were dosed at 1.65mcg, 3.3mcg, and 4.4mcg, respectively. Participants who received VAX-31 in Stage 1 continued the standard dosing regimen as part of Stage 2.

Previous wording

•VAX-A1, a novel conjugate vaccine candidate designed to prevent disease caused by Group A Streptococcus (Streptococcus pyogenes) (“Group A Strep”). Group A Strep is pervasive globally and causes an estimated 800 million cases of illness annually, including pharyngitis, or strep throat, and certain severe invasive infections and sequelae. There is currently no vaccine against Group A Strep, which is one of the leading infectious disease-related causes of death and disability worldwide and a significant contributor to the prescription of antibiotics in children. We believe we have demonstrated preclinical proof of concept for VAX-A1, the data for which were published in December 2020. We plan to initiate a Phase 1 adult study for VAX-A1 in mid-2026, with the primary objective of assessing safety and tolerability, along with a secondary objective of evaluating initial immunogenicity data, to support potential further advancement.

Current wording

•VAX-A1, a novel conjugate vaccine candidate designed to prevent disease caused by Group A Streptococcus (Streptococcus pyogenes) (“Group A Strep”). Group A Strep is pervasive globally and causes an estimated 800 million cases of illness annually, including pharyngitis, or strep throat, and certain severe invasive infections and sequelae. There is currently no vaccine against Group A Strep, which is one of the leading infectious disease-related causes of death and disability worldwide and a significant contributor to the prescription of antibiotics in children. We believe we have demonstrated preclinical proof of concept for VAX-A1, the data for which were published in December 2020. In June 2026, we initiated a Phase 1 adult study for VAX-A1, with the primary objective of assessing safety and tolerability, along with a secondary objective of evaluating initial immunogenicity data, to support potential further advancement. We expect to report topline data from this study in the second half of 2027.

Previous wording

•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 February 2026, we announced plans to advance the clinical development of our 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, along with a secondary objective of evaluating initial immunogenicity data, to support potential further advancement. 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. We expect to initiate a Phase 1 adult study in mid-2026.

Current wording

•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, we announced that the first participant was dosed in the Phase 1, first-in-human study evaluating VAX-A1, an investigational prophylactic vaccine candidate designed to prevent disease caused by Group A Strep, with the primary objective of assessing safety and tolerability, along with a secondary objective of evaluating initial immunogenicity data, to support potential further advancement. 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. 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.'

Previous wording

We have incurred net losses in each year since inception and expect to continue to incur net losses in the foreseeable future. Our net losses may fluctuate significantly from quarter-to-quarter and year-to-year, depending in large part on the timing of our clinical trials and manufacturing activities, and our expenditures on other research and development activities. Our net loss was $320.6 million for the three months ended March 31, 2026. As of March 31, 2026, we had an accumulated deficit of $2.5 billion and cash, cash equivalents and investments of $2.7 billion. We believe our cash, cash equivalents and investments will be sufficient to fund our operating expenses and capital expenditure requirements through at least 12 months from the filing date of this Quarterly Report on Form 10-Q.

Current wording

We have incurred net losses in each year since inception and expect to continue to incur net losses in the foreseeable future. Our net losses may fluctuate significantly from quarter-to-quarter and year-to-year, depending in large part on the timing of our clinical trials and manufacturing activities, and our expenditures on other research and development activities. Our net loss was $284.3 million and $604.9 million for the three and six months, respectively, ended June 30, 2026. As of June 30, 2026, we had an accumulated deficit of $2.8 billion and cash, cash equivalents and investments of $2.5 billion. We believe our cash, cash equivalents and investments will be sufficient to fund our operating expenses and capital expenditure requirements through at least 12 months from the filing date of this Quarterly Report on Form 10-Q.

Previous wording

We do not expect to generate any revenue from commercial product sales unless and until we successfully complete development and obtain regulatory approval for one or more of our vaccine candidates, which we expect will take a number of years. We expect our expenses will increase substantially in connection with our ongoing activities, as we:

Current wording

We do not expect to generate any revenue from commercial product sales unless and until we successfully complete development and obtain regulatory approval for one or more of our vaccine candidates, which we expect will take a number of years. We expect our expenses will increase in connection with our ongoing activities, as we:

Previous wording

Pursuant to the Lonza Commercial Manufacturing and Supply Agreement, Lonza will (i) construct and build out a dedicated suite (the “Suite”) at Lonza’s facilities in Visp, Switzerland to manufacture certain key components (including drug substance) for our proprietary PCV franchise and any other products or intermediates we may choose (collectively, the “Products”) and (ii) maintain and operate the Suite (utilizing Lonza’s employees) to manufacture the Products as a service provided to us, including conducting related quality control and quality assurance operations. Lonza will be a preferred, non-exclusive, supplier of the Products to us, and we retain the right to procure the Products from one or more alternate and/or backup manufacturers of the Products (including at our own facilities).

Current wording

Pursuant to the Lonza Commercial Manufacturing and Supply Agreement, Lonza constructed and built out a dedicated suite (the “Suite”) at Lonza’s facilities in Visp, Switzerland to manufacture certain key components (including drug substance) for our proprietary PCV franchise and any other products or intermediates we may choose (collectively, the “Products”). Following completion of construction and certification of the Suite for commercial operation, the Suite was handed over to the Lonza operations team on August 1, 2026, and Lonza will now maintain and operate the Suite (utilizing Lonza’s employees) to manufacture the Products as a service provided to us, including conducting related quality control and quality assurance operations. Lonza is a preferred, non-exclusive, supplier of the Products to us, and we retain the right to procure the Products from one or more alternate and/or backup manufacturers of the Products (including at our own facilities).

Previous wording

Under the Lonza Commercial Manufacturing and Supply Agreement, prior to completion of construction and certification of the Suite for commercial operation, we will contribute to the capital expenditure costs to construct the Suite (and will own certain equipment in the Suite to be purchased or otherwise acquired by us), and will pay Lonza a fixed-rate monthly service fee for Lonza’s pre-commercial services prior to commencement of commercial operations (which monthly service fee amount is subject to increases in subsequent years). Following commencement of commercial operations of the Suite to manufacture the Products, we will pay Lonza (i) Suite fees based on allocations of certain of Lonza’s costs to maintain the facility in which the Suite is located and to provide shared services to us and Lonza’s other customers in such facility, (ii) service fees based upon Lonza’s actual full-time equivalent employee (“FTE”) costs to operate the Suite to manufacture the Products, and (iii) certain other pass-through costs, including for raw materials. In addition, we may be obligated to pay or reimburse Lonza for certain other fees and expenses under the Lonza Commercial Manufacturing and Supply Agreement. Lonza will be eligible for certain financial bonuses, and subject to certain financial penalties, as incentives for the timely completion of certain scale-up activities, receipt of certain regulatory approvals for the Suite and manufacture of the Products in accordance with our commercial requirements.

Current wording

Under the Lonza Commercial Manufacturing and Supply Agreement, prior to completion of construction and certification of the Suite for commercial operation, we contributed to the capital expenditure costs to construct the Suite (and own certain equipment in the Suite that was purchased or otherwise acquired by us), and paid Lonza a fixed-rate monthly service fee for Lonza’s pre-commercial services prior to commencement of commercial operations. We will now pay Lonza (i) Suite fees based on allocations of certain of Lonza’s costs to maintain the facility in which the Suite is located and to provide shared services to us and Lonza’s other customers in such facility, (ii) service fees based upon Lonza’s actual full-time equivalent employee (“FTE”) costs to operate the Suite to manufacture the Products, and (iii) equipment expenditures and certain other pass-through costs, including for raw materials. In addition, we may be obligated to pay or reimburse Lonza for certain other fees and expenses under the Lonza Commercial Manufacturing and Supply Agreement. Lonza will be eligible for certain financial bonuses, and subject to certain financial penalties, as incentives for the timely completion of certain scale-up activities, receipt of certain regulatory approvals for the Suite and manufacture of the Products in accordance with our commercial requirements.

Previous wording

In May 2018, we entered into a supply agreement with Sutro Biopharma, which was subsequently amended on February 22, 2021 and November 21, 2023 (as amended, the “Sutro Biopharma Supply Agreement”) pursuant to which we purchase from Sutro Biopharma extract and custom reagents for use in manufacturing non-clinical and certain clinical supply of vaccine compositions utilizing the technology licensed under the Sutro Biopharma License at prices not to exceed a specified percentage above Sutro Biopharma’s fully burdened manufacturing cost. If any extracts or custom reagents do not meet the specifications and warranties provided, then we will not have an obligation to pay for the non-conforming product, and Sutro Biopharma will be obligated to replace the non-conforming product within the shortest possible time with conforming product at our cost. The term of the Sutro Biopharma Supply Agreement is from execution until the later of (i) July 31, 2022, or (ii) the date that we and Sutro Biopharma enter into the Phase 3/Commercial Supply Agreement and Sutro Biopharma is supplying to us each Product under the Phase 3/Commercial Supply Agreement (each term as defined in the Sutro Biopharma Supply Agreement). The Sutro Biopharma Supply Agreement may be terminated by either party for the other party’s material breach uncured within 60 days’ notice, by us at will with 60 days’ notice, or by mutual agreement of the parties. In December 2019, we exercised our right to require Sutro Biopharma to establish a second supplier for extract and custom reagents to support our anticipated clinical and commercial needs.

Current wording

In May 2018, we entered into a supply agreement with Sutro Biopharma, which was subsequently amended on February 22, 2021 and November 21, 2023 (as amended, the “Sutro Biopharma Supply Agreement”) pursuant to which we purchase from Sutro Biopharma extract and custom reagents for use in manufacturing non-clinical and certain clinical supply of vaccine compositions utilizing the technology licensed under the Sutro Biopharma License at prices not to exceed a specified percentage above Sutro Biopharma’s fully burdened manufacturing cost. If any extracts or custom reagents do not meet the specifications and warranties provided, then we will not have an obligation to pay for the non-conforming product, and Sutro Biopharma will be obligated to replace the non-conforming product within the shortest possible time with conforming product at our cost. The term of the Sutro Biopharma Supply Agreement is from execution until the later of (i) July 31, 2022, or (ii) the date that we and Sutro Biopharma enter into the Phase 3/Commercial Supply Agreement and

Previous wording

As consideration for the Option and other rights and authorizations granted to us under the Option Agreement, we paid Sutro Biopharma upfront consideration of $22.5 million, consisting of (i) $10.0 million in cash and $7.5 million worth of shares of our common stock (the number of shares calculated based on the arithmetic average of the daily volume weighted average price of our common stock as traded on Nasdaq in the three consecutive trading days immediately prior to the issuance thereof) in December 2022, and (ii) $5.0 million in October 2023 within five business days after we and Sutro

Current wording

As consideration for the Option and other rights and authorizations granted to us under the Option Agreement, we paid Sutro Biopharma upfront consideration of $22.5 million, consisting of (i) $10.0 million in cash and $7.5 million worth of shares of our common stock (the number of shares calculated based on the arithmetic average of the daily volume weighted average price of our common stock as traded on Nasdaq in the three consecutive trading days immediately prior to the issuance thereof) in December 2022, and (ii) $5.0 million in October 2023 within five business days after we and Sutro Biopharma mutually agree in writing upon the Form Definitive Agreement on September 28, 2023. The 167,780 shares of common stock issued was recorded at fair value of $8.0 million on the date of settlement, December 22, 2022.

Previous wording

Our PCV programs include VAX-31, VAX-24 and VAX-XL, and our non-PCV programs include VAX-A1, VAX-GI, and other discovery-stage programs. In August 2025, we announced that we paused the advancement, beyond preclinical development, of VAX-A1 and VAX-GI while remaining confident in their potential and preserving the option to advance the programs in the future. We now plan to initiate a Phase 1 adult study for VAX-A1 in mid-2026. The majority of our external costs relate to our PCV programs compared to the costs related to non-PCV programs. Most of the external costs associated with our vaccine candidates, particularly our PCV programs, are common in nature, and can be deployed across multiple candidates or redeployed as our vaccine development strategy evolves; as a result, we do not track external costs by candidate, program or project. We do not allocate internal personnel-related costs by program or project because several of our departments support multiple vaccine candidate programs and the hours are not tracked separately by program.

Current wording

Our PCV programs include VAX-31, VAX-24 and VAX-XL, and our non-PCV programs include VAX-A1, VAX-GI, and other discovery-stage programs. In August 2025, we announced that we paused the advancement, beyond preclinical development, of VAX-A1 and VAX-GI while remaining confident in their potential and preserving the option to advance the programs in the future. In June 2026, we initiated a Phase 1 adult study for VAX-A1. The majority of our external costs relate to our PCV programs compared to the costs related to non-PCV programs. Most of the external costs associated with our vaccine candidates, particularly our PCV programs, are common in nature, and can be deployed across multiple candidates or redeployed as our vaccine development strategy evolves; as a result, we do not track external costs by candidate, program or project. We do not allocate internal personnel-related costs by program or project because several of our departments support multiple vaccine candidate programs and the hours are not tracked separately by program.

Previous wording

Income from grants is recognized in the period during which the related specified expenses are incurred, provided that the conditions under which the grants were provided have been met. The amount of grant income was not material during the three months ended March 31, 2026 and March 31, 2025. Grant income is included as a component of Other income, net in the condensed consolidated statements of operations.

Current wording

Income from grants is recognized in the period during which the related specified expenses are incurred, provided that the conditions under which the grants were provided have been met. The amount of grant income was not material during the three and six months ended June 30, 2026 and June 30, 2025. Grant income is included as a component of Other income, net in the condensed consolidated statements of operations.

Previous wording

Comparison of the Three Months Ended March 31, 2026 and 2025

Current wording

Comparison of the Three and Six Months Ended June 30, 2026 and 2025

Previous wording

Research and development expenses increased by $164.6 million, or 111.1%, during the three months ended March 31, 2026 compared to the corresponding period in 2025. The increase was driven by external costs, which grew by $152.6 million largely due to increased development and manufacturing activities in connection with our PCV programs. Product manufacturing costs increased by $101.8 million, primarily driven by an increase in manufacturing activities, including to support the potential future commercial launches, clinical trials-related expenses increased by $45.0 million, primarily due to the initiation of and enrollment in the VAX-31 OPUS-1, OPUS-2 and OPUS-3 Phase 3 studies, facility and other allocated costs increased by $3.9 million, and research expenses increased by $1.3 million compared to the corresponding period in 2025. The increase was further driven by internal personnel-related costs, which grew by $12.0 million largely due to headcount growth.

Current wording

Research and development expenses increased by $238.3 million, or 69.6% during the six months ended June 30, 2026 compared to the corresponding period in 2025. The increase was driven by external costs, which grew by $216.7 million largely due to increased activities related to product manufacturing and clinical trials in connection with our PCV programs. Product manufacturing costs increased by $127.0 million due to an increase in manufacturing activities, including to support the potential future commercial launches, Clinical trials-related expenses increased by $70.5 million, primarily due to the initiation of and enrollment in the VAX-31 OPUS-1, OPUS-2 and OPUS-3 Phase 3 studies, Research expenses increased by $16.1 million, and other external costs increased by $2.5 million compared to the corresponding period in 2025. The increase was further driven by internal personnel-related costs, which grew by $21.6 million largely due to headcount growth.

Previous wording

Other income, net decreased by $14.8 million, or 37.0%, during the three months ended March 31, 2026 compared to the corresponding period in 2025. The decrease was primarily attributable to a $9.4 million reduction in unrealized and realized foreign currency gains due to fluctuations in the foreign currency exchange rates and a $6.3 million decrease in interest income as a result of lower cash and investment balances and lower interest rates during the period.

Current wording

Other income, net decreased by $41.2 million, or 69.0%, during the three months ended June 30, 2026 compared to the corresponding period in 2025. The decrease was primarily attributable to a $35.9 million reduction in unrealized and realized foreign currency gains due to fluctuations in the foreign currency exchange rates and a $5.3 million decrease in interest income as a result of lower cash and investment balances and lower interest rates during the period.

Previous wording

From inception through March 31, 2026, we have incurred losses and negative cash flows from operations and have funded our operations primarily through the issuance of common stock, pre-funded warrants to purchase our common stock and, prior to our IPO, redeemable convertible preferred stock, totaling approximately $5.3 billion in aggregate gross proceeds and $5.1 billion net of underwriting discounts, commissions and offering expenses. As of March 31, 2026, we had $0.3 billion in cash and cash equivalents, $2.5 billion in investments and an accumulated deficit of $2.5 billion.

Current wording

From inception through June 30, 2026, we have incurred losses and negative cash flows from operations and have funded our operations primarily through the issuance of common stock, pre-funded warrants to purchase our common stock and, prior to our IPO, redeemable convertible preferred stock, totaling approximately $5.3 billion in aggregate gross proceeds and $5.1 billion net of underwriting discounts, commissions and offering expenses. As of June 30, 2026, we had $0.2 billion in cash and cash equivalents, $2.3 billion in investments and an accumulated deficit of $2.8 billion.

Previous wording

On February 24, 2026, we entered into a Sales Agreement (the "2026 ATM Sales Agreement") with Leerink Partners LLC ("Leerink Partners"), to issue and sell, from time to time at our discretion, shares of our common stock at an aggregate offering price up to $500.0 million through Leerink Partners as our sales agent. We will pay Leerink Partners a commission of up to 3.0% of the gross sales proceeds of any common stock sold through Leerink Partners under the 2026 ATM Sales

Current wording

On February 24, 2026, we entered into a Sales Agreement (the "2026 ATM Sales Agreement") with Leerink Partners LLC ("Leerink Partners"), to issue and sell, from time to time at our discretion, shares of our common stock at an aggregate offering price up to $500.0 million through Leerink Partners as our sales agent. We will pay Leerink Partners a commission of up to 3.0% of the gross sales proceeds of any common stock sold through Leerink Partners under the 2026 ATM Sales Agreement; however, we are not obligated to make any sales of common stock. As of June 30, 2026, we have not sold any shares of our common stock under the 2026 ATM Sales Agreement.

Previous wording

During the three months ended March 31, 2025, 3,500,000 shares underlying the pre-funded warrants were exercised to receive 3,499,959 shares of common stock, net of exercise costs. No shares underlying the pre-funded warrants were exercised during the three months ended March 31, 2026. As of both March 31, 2026 and December 31, 2025, a total of 5,463,793 shares underlying pre-funded warrants were outstanding.

Current wording

During the three and six months ended June 30, 2025, 640,705 and 4,140,705 shares underlying the pre-funded warrants were exercised, respectively, to receive 640,685 and 4,140,644 shares of common stock, respectively, net of exercise costs. No shares underlying the pre-funded warrants were exercised during the three and six months ended June 30, 2026. As of both June 30, 2026 and December 31, 2025, a total of 5,463,793 shares underlying pre-funded warrants were outstanding.

Previous wording

Net cash used in operating activities for the three months ended March 31, 2026 was $280.6 million, an increase of $114.4 million compared to the three months ended March 31, 2025. The increase was primarily due to higher cash expenditures to support our business growth, including increased development and manufacturing activities in connection with the adult and infant PCV programs to support the potential future commercial launches, as well as timing of payments.

Current wording

Net cash used in operating activities for the six months ended June 30, 2026 was $513.1 million, an increase of $225.7 million compared to the six months ended June 30, 2025. The increase was primarily due to higher cash expenditures to support our business growth, including increased development and manufacturing activities in connection with the adult and infant PCV programs to support the potential future commercial launches, as well as timing of payments.

Previous wording

Net cash used in investing activities for the three months ended March 31, 2026 was $233.4 million, an increase of $356.7 million compared to net cash provided by investing activities for the three months ended March 31, 2025. The change was primarily attributable to a $269.6 million increase in purchases of investments and a $99.0 million decrease in maturities and sales of investments, which were partially offset by a $12.0 million decrease in purchases of property and equipment, manufacturing facility build-out and equipment construction-in-progress.

Current wording

Net cash used in investing activities for the six months ended June 30, 2026 was $85.7 million, an increase of $286.8 million compared to net cash provided by investing activities for the six months ended June 30, 2025. The change was primarily attributable to a $189.3 million increase in purchases of investments and a $114.6 million decrease in maturities and sales of investments.

Previous wording

Net cash provided by financing activities for the three months ended March 31, 2026 was $601.6 million, an increase of $600.8 million compared to the three months ended March 31, 2025. The increase was primarily due to the proceeds of $601.8 million, net of issuance costs, from the follow-on offering during the three months ended March 31, 2026, whereas no such offerings occurred during the three months ended March 31, 2025.

Current wording

Net cash provided by financing activities for the six months ended June 30, 2026 was $607.3 million, an increase of $604.0 million compared to the six months ended June 30, 2025. The increase was primarily due to $601.8 million in net proceeds from the follow-on offering during the six months ended June 30, 2026, whereas no such offerings occurred during the six months ended June 30, 2025.

Previous wording

We have operating lease agreements for our office spaces. As of March 31, 2026, we had total lease payment obligations of $161.0 million, of which $12.8 million is payable within one year.

Current wording

We have operating lease agreements for our office spaces. As of June 30, 2026, we had total lease payment obligations of $158.2 million, of which $13.7 million is payable within one year.
Rearranged current paragraphs (2)

Current report — wording carried from elsewhere

Sutro Biopharma is supplying to us each Product under the Phase 3/Commercial Supply Agreement (each term as defined in the Sutro Biopharma Supply Agreement). The Sutro Biopharma Supply Agreement may be terminated by either party for the other party’s material breach uncured within 60 days’ notice, by us at will with 60 days’ notice, or by mutual agreement of the parties. In December 2019, we exercised our right to require Sutro Biopharma to establish a second supplier for extract and custom reagents to support our anticipated clinical and commercial needs.

Current report — wording carried from elsewhere

Other income, net decreased by $56.0 million, or 56.2%, during the six months ended June 30, 2026 compared to the corresponding period in 2025. The decrease was primarily attributable to a $44.4 million reduction in unrealized and realized foreign currency gains due to fluctuations in the foreign currency exchange rates and a $11.6 million decrease in interest income as a result of lower cash and investment balances and lower interest rates during the period.
Rearranged previous paragraphs (4)

Previous report — wording carried elsewhere

◦OPUS-2: In January 2026, we announced the first patients had been dosed in this Phase 3 trial evaluating VAX-31 when administered concomitantly with a licensed seasonal influenza vaccine in pneumococcal- naïve adults aged 50 years and older. In March 2026, we announced we completed enrollment of this trial with 1,390 participants dosed.

Previous report — wording carried elsewhere

•Completed Public Offering Generating Gross Proceeds of $632.5 Million: In February 2026, we completed an underwritten public offering of 12,650,000 shares of 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 us from this offering were $632.5 million, before deducting underwriting discounts and commissions and other offering expenses payable by us.

Previous report — wording carried elsewhere

Biopharma mutually agree in writing upon the Form Definitive Agreement on September 28, 2023. The 167,780 shares of common stock issued was recorded at fair value of $8.0 million on the date of settlement, December 22, 2022.

Previous report — wording carried elsewhere

Agreement; however, we are not obligated to make any sales of common stock. As of March 31, 2026, we have not sold any shares of our common stock under the 2026 ATM Sales Agreement.