Vaxcyte, Inc.
For the period ended Mar 31, 2026. Filed May 6, 2026.
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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.
Mar 31, 2026 · Filed May 6, 2026
PCVX$63.89+3.2%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2025-09-30; filed 2025-11-04.
0001649094-25-000114
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent 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 OperationsThe 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 201 previous paragraphs and 202 current paragraphs.
135 unchanged; 40 reworded; 23 added; 17 removed; 9 previous and 4 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 (23)
Current report
•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 report
•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 report
•The final data from the VAX-24 infant Phase 2 dose-finding study further supported our rationale for exploring higher doses in the ongoing VAX-31 infant Phase 2 study.
Current 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:
Current 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.
Current report
◦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.
Current 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.
Current 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.
Current 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.
Current report
•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 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.
Current 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.
Current report
•scale medical affairs and commercial infrastructure to support anticipated product launches;
Current report
2026 Development and Manufacturing Services Agreement
Current report
In February 2026, we entered into a development and manufacturing services agreement with Lonza, effective as of January 1, 2026, pursuant to which Lonza will perform manufacturing process development and commercial manufacture and supply of certain key components for our proprietary PCV franchise. Under the agreement, we will pay Lonza for development and manufacturing services, in addition to paying for certain raw material and other costs. We will be required to purchase, and Lonza will be required to supply, the components pursuant to the relevant purchase orders under the agreement. In consideration of the commercial supply services and Lonza’s other obligations under the agreement, we will pay Lonza a daily fee for Lonza’s operation of the facility solely to actively manufacture the components. With respect to such commercial supply, and subject to termination rights, we and Lonza have agreed to a mutually binding percentage of annual facility capacity that shall be utilized by Lonza fully and exclusively for Lonza’s performance of services thereunder, which percentages may be adjusted under certain circumstances.
Current report
Unless earlier terminated, the agreement will remain in effect until December 31, 2038, subject to automatic renewal for up to three additional renewal periods of five years each, unless we elect not to renew. We may terminate the agreement for convenience, and the agreement contains customary for-cause termination rights for each party. If the Agreement is terminated (i) by us for convenience, or (ii) by Lonza for our uncured failure to pay material, undisputed amounts of money due to Lonza, then we shall pay Lonza certain cancellation fees as specified in the agreement.
Current report
Amended and Restated License Agreement
Current report
Supply Agreement
Current report
Manufacturing Rights Agreement
Current report
Commercial Manufacturing and Supply Agreement
Current 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.
Current report
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 report
Option Agreement
Removed paragraphs (17)
Previous report
•In September 2025, we announced that this study had advanced to the third and final stage with the first participants receiving the Optimized dose and both the Middle dose and High dose VAX-31 arms proceeding as planned.
Previous report
•Following Interactions with FDA on VAX-31 Adult Program, Including End-of-Phase 2 Meeting, We Are Finalizing Phase 3 Clinical Program to Validate VAX-31 as Potential New Standard-of-Care Adult PCV to Prevent IPD and Pneumonia: In August 2025, we announced that 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 BTD, the FDA provided input on the chemistry, manufacturing and controls (“CMC”) licensure requirements in support of our path to delivering a BLA submission. We are 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 December 2025, 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 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 2027, we plan to submit a BLA shortly following the completion of the last Phase 3 study.
Previous report
•Advanced Ongoing VAX-31 Infant Phase 2 Dose-Finding Study with First Participants Receiving Optimized Dose: In August 2025, we announced that we had 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. In September 2025, we announced that the first participants had received the Optimized dose, and that the modified study had progressed to the third and final stage. Both the Middle dose and High dose VAX-31 arms in the study have proceeded as planned, and we discontinued enrollment in the Low dose arm. The modified study is evaluating VAX-31 in approximately 900 participants, including the 100 participants previously enrolled in the Low dose arm. We expect to announce topline data from the primary immunization series and the booster dose either sequentially or together by the end of the first half of 2027.
Previous report
•Announced Plan to Establish Fill-Finish Manufacturing in North Carolina as Key Element of Long-Term U.S. Commercial Supply Strategy Representing Up to $1 Billion in Manufacturing and Services: In September 2025, we announced a new agreement with Patheon Manufacturing Services, LLC, part of Thermo Fisher Scientific (collectively, "Thermo Fisher") to provide custom commercial fill-finish capacity for our broad-spectrum PCVs at Thermo Fisher's Greenville, North Carolina facility. The initiative, which includes both manufacturing and related services, represents a long-term U.S. commercial manufacturing commitment of up to $1 billion.
Previous report
•Appointed Mike Mullette as Chief Commercial Officer to Lead Commercialization Strategy and Execution: In October 2025, Michael Mulletta 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 our strategy to prepare for future commercialization of our 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.
Previous report
Supply Agreement with Sutro Biopharma
Previous report
Option Agreement with Sutro Biopharma
Previous report
Manufacturing Rights Agreement with Sutro Biopharma
Previous report
Commercial Manufacturing and Supply Agreement with Thermo Fisher
Previous report
The following table summarizes our research and development expenses for the periods presented:
Previous report
Research and development expenses increased by $209.2 million, or 61.0%, during the nine months ended September 30, 2025 compared to the corresponding period in 2024. The increase was driven by external costs, which grew by $156.1 million largely due to increased development and manufacturing activities in connection with the adult and infant PCV programs and to support the potential future commercial launches. Product manufacturing costs increased by $122.4 million, research and development consumables, lab supplies and equipment increased by $17.2 million, facility and allocated costs increased by $9.6 million, other external costs increased by $4.0 million, and clinical costs increased by
Previous report
General and administrative expenses increased by $9.5 million, or 41.1%, during the three months ended September 30, 2025 compared to the corresponding period in 2024. The increase was primarily attributable to higher personnel-related costs, largely due to headcount growth.
Previous report
General and administrative expenses increased by $32.8 million, or 51.0%, during the nine months ended September 30, 2025 compared to the corresponding period in 2024. The increase was primarily attributable to higher personnel-related costs, largely due to headcount growth and, to a lesser extent, facilities costs and professional services costs related to corporate affairs activities.
Previous report
Other income, net increased by $48.7 million, or 60.5%, during the nine months ended September 30, 2025 compared to the corresponding period in 2024. The increase was primarily attributable to a $30.2 million increase in unrealized and realized foreign currency gains due to the weakening of the US Dollar relative to the Swiss Franc, an $19.7 million increase in interest income as a result of higher cash and investment balances resulting from our follow-on equity and ATM financings, combined with increases in interest rates resulting from a longer average investment portfolio duration.
Previous report
On January 13, 2022, we completed an underwritten public offering in which we issued 2,500,000 shares of our common stock at a price of $20.00 per share and pre-funded warrants to purchase 2,500,000 shares of our common stock at a price of $19.999 per underlying share. Each pre-funded warrant has an exercise price of $0.001 per share. In February 2022, the underwriters exercised their option to purchase an additional 750,000 shares of common stock. In aggregate, we received $107.6 million in net proceeds after deducting issuance costs, and excluding the exercise of any pre-funded warrants.
Previous report
On October 28, 2022, we completed an underwritten public offering of 17,812,500 shares of our common stock, which included the full exercise of the underwriters’ option to purchase an additional 2,812,500 shares, at a price of $32.00 per share and pre-funded warrants to purchase 3,750,000 shares of our common stock at a price of $31.999 per underlying share. Each pre-funded warrant has an exercise price of $0.001 per share. In aggregate, we received $651.6 million in net proceeds after deducting issuance costs, and excluding the exercise of any pre-funded warrants.
Previous report
On April 21, 2023, we completed an underwritten public offering of 13,030,000 shares of our common stock, which included the full exercise of the underwriters’ option to purchase an additional 1,830,000 shares, at a price of $41.00 per share and pre-funded warrants to purchase 1,000,000 shares of our common stock at a price of $40.999 per underlying share. Each pre-funded warrant has an exercise price of $0.001 per share. In aggregate, we received $545.3 million in net proceeds after deducting issuance costs, and excluding the exercise of any pre-funded warrants.
Reworded paragraphs (40)
Previous wording
We are a clinical-stage vaccine innovation company engineering high-fidelity vaccines designed to protect humankind from the consequences of bacterial diseases. We are developing broad-spectrum conjugate and novel protein vaccines to prevent or treat bacterial infectious diseases. We are 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. (“Sutro Biopharma”). Unlike conventional cell-based approaches, our system for producing difficult-to-make proteins and antigens is intended to accelerate our ability to efficiently create and deliver high-fidelity vaccines with enhanced immunological benefits.
Current wording
We are a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases. We are re-engineering the way highly complex vaccines are made through the XpressCF™ cell-free protein synthesis platform. Unlike conventional cell-based approaches, our system for producing difficult-to-make proteins and antigens is intended to develop and deliver high-fidelity vaccines with enhanced immunological benefits that are beyond the capabilities of conventional approaches.
Previous wording
•Pneumococcal conjugate vaccine (“PCV”) candidates that we believe are among the broadest-spectrum PCV candidates currently in development, targeting the approximately $8 billion global pneumococcal vaccine market. Pneumococcal disease ("PD") is an infection caused by Streptococcus pneumoniae bacteria. It can result in invasive pneumococcal disease (“IPD”), including meningitis and bacteremia, and non-invasive PD, including pneumonia, otitis media and sinusitis. Our broad-spectrum, carrier-sparing PCV candidates, VAX-31, VAX-24 and VAX-XL, are designed to improve upon standard-of-care PCVs for both adults and children by covering the serotypes that are responsible for a significant portion of IPD in circulation 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.
Current wording
•PCV candidates that we believe are among the broadest-spectrum PCV candidates currently in development, targeting the approximately $8 billion global pneumococcal vaccine market. Pneumococcal disease ("PD") is an infection caused by Streptococcus pneumoniae bacteria. It can result in invasive pneumococcal disease (“IPD”), including meningitis and bacteremia, and non-invasive PD, including pneumonia, otitis media and sinusitis. Our broad-spectrum, carrier-sparing PCV candidates, VAX-31, VAX-24 and VAX-XL, are designed to improve upon standard-of-care PCVs for both adults and children by covering the serotypes that are responsible for increasing portions of IPD in circulation 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.
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 circulating in adults in the United States aged 50 and older, with the potential to provide an incremental 14-34% of coverage 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 14-34% of coverage for IPD and an incremental 19-31% of coverage for pneumococcal pneumonia over current standard-of-care adult PCVs.
Previous wording
Based on these positive results and the totality of VAX-31 data in adults, we selected the VAX-31 High dose (all serotypes dosed at 3.3mcg or 4.4mcg) to advance to an adult Phase 3 program. We plan to initiate the Phase 3 pivotal, non-inferiority study in December 2025 and announce topline safety, tolerability and immunogenicity data from this study in 2026. We plan to initiate the remaining Phase 3 studies in 2026 and announce data from those studies in 2027. Subject to the results of the Phase 3 studies, we plan to submit a Biologics License Application (“BLA”) shortly following the completion of the last Phase 3 study.
Current wording
Based on these positive results, we selected the High Dose of VAX-31 to advance to an adult Phase 3 program.
Previous wording
•In November 2024, we announced that the U.S. Food and Drug Administration ("FDA") granted a breakthrough therapy designation ("BTD") for VAX-31 for the prevention of IPD in adults.
Current wording
•In November 2024, we announced that the U.S. Food and Drug Administration ("FDA") granted breakthrough therapy designation ("BTD") for VAX-31 for the prevention of IPD in adults and, in August 2025, we announced that the FDA expanded the BTD for VAX-31 to include the prevention of pneumonia caused by Streptococcus pneumoniae.
Previous wording
▪VAX-31 is a 31-valent, broad-spectrum, carrier-sparing investigational PCV being developed for the prevention of IPD in not only adults, but also in children. VAX-31 is the broadest-spectrum PCV in the clinic designed to cover approximately 92% of IPD and 93% of acute otitis media due to Streptococcus pneumoniain children under five years of age in the United States.
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 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.
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, 3.3mcg, and 4.4mcg, respectively. Participants who received VAX-31 in Stage 1 will continue the standard dosing regimen as part of Stage 2 and will be included in the safety, tolerability and immunogenicity analysis of the study.
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 3.3mcg, respectively, except serotypes 1, 5 and 22F, which were dosed at 1.65mcg,
Previous wording
•The modified study is evaluating the safety, tolerability and immunogenicity of VAX-31 and compared to PCV20 in approximately 900 participants, including the 100 participants previously enrolled in the Low dose arm. The study design includes a primary immunization series consisting of three doses given at two months, four months and six months of age, followed by a subsequent booster dose at 12-15 months of age.
Current wording
▪In February 2025, we announced that the Phase 2, randomized, dose-finding study of VAX-31 in healthy infants had advanced to the second stage of the study. Stage 2 of the study is evaluating the safety, tolerability and immunogenicity of VAX-31 at the same three dose levels evaluated in Stage 1 and compared to PCV20. In line with recommendations from the ACIP, the study design includes a primary immunization series consisting of three doses given at two months, four months and six months of age, followed by a subsequent booster dose at 12-15 months of age.
Previous wording
•In August 2025, we announced that we had modified the ongoing VAX-31 infant Phase 2 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. We also announced that both the Middle dose and High dose VAX-31 arms in the study would proceed, while we had elected to discontinue enrollment in the Low dose arm.
Current wording
▪In September 2025, we announced advancement of the VAX-31 infant Phase 2 randomized, dose-finding study to the third and final stage following modifications to the protocol to add a new dose arm to evaluate a VAX-31 Optimized Dose (majority of serotypes dosed at 4.4mcg and the balance dosed at 3.3mcg) and discontinue further enrollment in the Low Dose arm. The Middle and High Dose arms continued as planned.
Previous wording
•We expect to announce topline safety, tolerability and immunogenicity data for the Phase 2 randomized, dose-finding study from the primary three-dose immunization series and booster dose either sequentially or together by the end of the first half of 2027.
Current wording
▪In January 2026, we announced that we completed enrollment of this study. We expect to announce topline safety, tolerability and immunogenicity data from the primary three-dose immunization series and booster dose either sequentially or together by the end of the first half of 2027.
Previous wording
•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.
Current wording
▪Pending the VAX-31 Phase 2 infant study readout, we plan to initiate a Phase 3 program in infants with an Optimized Dose formulation of VAX-24 or VAX-31.
Previous wording
•In November 2025, we announced final safety, tolerability, and immunogenicity results from the VAX-24 infant Phase 2 study, that were consistent with the positive interim data reported in March 2025 and showed that VAX-24 elicited robust, dose-dependent immune responses, with little to no evidence of carrier suppression observed. The final data analysis included full 6-month safety results and complete post-dose 3 (primary immunization series) and post-dose 4 (booster dose) IgG and OPA results. The key immunogenicity endpoints included an assessment of immune responses for each of the VAX-24 dose levels (Low, Mid, Mixed) in comparison with 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 GMRs were also assessed at 1-month post-dose 3 and post-dose 4, along with other key immunogenicity endpoints, including OPA.
Current wording
•In November 2025, we announced final safety, tolerability, and immunogenicity results from the VAX-24 infant Phase 2 study that were consistent with the positive interim data reported in March 2025 and showed that VAX-24 elicited robust, dose-dependent immune responses, with little to no evidence of carrier suppression observed. The final data analysis included full 6-month safety results and complete post-dose 3 (primary immunization series) and post-dose 4 (booster dose) IgG and OPA results. The key immunogenicity endpoints included an assessment of immune responses for each of the VAX-24 dose levels (Low, Mid, Mixed) compared to 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 GMRs were also assessed at 1-month post-dose 3 and post-dose 4, along with other key immunogenicity endpoints, including OPA.
Previous wording
•Post-dose 3, all VAX-24 doses met target precedent Phase 2 non-inferiority criteria on relative seroconversion rates (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 serotype) for the highest circulating serotypes contained in VAX-24. The Low and Mid doses met the non-inferiority 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 >0.6 for 21 of 24 serotypes.
Current wording
•Post-dose 3, all VAX-24 doses met target precedent Phase 2 non-inferiority criteria on relative seroconversion rates (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 serotype) for the highest circulating serotypes, as defined by the percentage of IPD caused in individuals <5 yrs of age in the U.S. in 2023 based on the U.S. Center for Disease Control ("CDC") active bacterial core ("ABC") surveillance data, contained in VAX-24. The Low and Mid doses met the seroconversion rate 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 >0.6 for 21 of 24 serotypes.
Previous wording
◦VAX-XL, a third-generation PCV candidate designed to provide the broadest coverage of any PCV currently in development.
Current wording
◦VAX-XL is a third-generation PCV candidate designed to provide the broadest coverage of any PCV currently in development.
Previous wording
•VAX-A1, a novel conjugate vaccine candidate designed to prevent disease caused by Group A Streptococcus (“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 nominated the final vaccine candidate for VAX-A1 in the first quarter of 2021 and initiated Investigational New Drug ("IND")-enabling activities in the second half of 2021. As part of our continued focus on strategic capital deployment and in order to prioritize our resources towards our PCV franchise, we announced in August 2025 that we had paused the advancement, beyond preclinical development, of VAX-A1 while remaining confident in its potential and preserving the option to advance the program in the future.
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. 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.
Previous wording
•VAX-GI, a novel preclinical vaccine candidate being developed as a preventative treatment for dysentery and shigellosis, which is caused by Shigella bacteria. Shigella is a bacterial illness that is estimated to cause 80 million to 165 million cases of disease and 600,000 deaths annually, mostly among children. The central antigen in VAX-GI is IpaB, a well-appreciated antigen that other developers have been unable to produce in an amount sufficient to enable a commercial product. With our cell-free technology, we believe we can produce this antigen at substantially improved yields, allowing for commercial-scale production. VAX-GI is being developed in collaboration with the University of Maryland, Baltimore as well as with partial funding from two research grants awarded by the National Institutes of Health ("NIH"). As part of our continued focus on strategic capital deployment and in order to prioritize our resources towards our PCV franchise, we announced in August 2025 that we had paused the advancement, beyond preclinical development, of VAX-GI while remaining confident in its potential and preserving the option to advance the program in the future.
Current wording
•VAX-GI, a novel preclinical vaccine candidate being developed as a preventative treatment for dysentery and shigellosis, which is caused by Shigella bacteria. Shigella is a bacterial illness estimated to cause 80 million to 165 million cases of disease and 600,000 deaths annually, mostly among children. The central antigen in VAX-GI is IpaB, a well-appreciated antigen that other developers have been unable to produce in an amount sufficient to enable a commercial product. With our cell-free technology, we believe we can produce this antigen at substantially improved yields, allowing for commercial-scale production. VAX-GI is being developed in collaboration with the University of Maryland, Baltimore as well as with partial funding from two research grants awarded by the National Institutes of Health (“NIH”). As part of our continued focus on strategic capital deployment and in order to prioritize our resources towards our PCV franchise, we announced in August 2025 that we had paused the advancement, beyond preclinical development, of VAX-GI while remaining confident in its potential and preserving the option to advance the program in the future.
Previous wording
In September 2024, we completed an underwritten public offering of 12,087,378 shares of our common stock, which included the full exercise of the underwriters’ option to purchase an additional 1,893,203 shares, at a price of $103.00 per share and pre-funded warrants to purchase 2,427,184 shares of our common stock at a price of $102.999 per underlying share. In aggregate, we received $1.4 billion in net proceeds after deducting underwriting discounts and commissions and other offering expenses payable by us, and excluding the exercise of any pre-funded warrants.
Current wording
•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 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 $212.8 million and $520.1 million for the three and nine months ended September 30, 2025, respectively. As of September 30, 2025, we had an accumulated deficit of $1.9 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 $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.
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 and capital expenditures will increase 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 substantially in connection with our ongoing activities, as we:
Previous wording
We rely and will continue to rely on third parties to conduct our preclinical studies and clinical trials and for manufacturing and supply of our vaccine candidates. We have no internal manufacturing capabilities, and we will continue to rely on third parties, of which the main suppliers are single-source suppliers, for our preclinical and clinical trial materials. Given our stage of development, we do not yet have a marketing or sales organization or commercial infrastructure. Accordingly, if we obtain regulatory approval for any of our vaccine candidates, we also would expect to incur significant commercialization expenses related to product sales, marketing, manufacturing and distribution.
Current wording
We rely and will continue to rely on third parties to conduct our preclinical studies and clinical trials and for manufacturing and supply of our vaccine candidates. We have no internal manufacturing capabilities, and we will continue to rely on third parties, of which the main suppliers are single-source suppliers, for our preclinical and clinical trial materials. Given our stage of development, we do not yet have a marketing or sales organization and have a limited commercial infrastructure. Accordingly, if we obtain regulatory approval for any of our vaccine candidates, we also would expect to incur significant commercialization expenses related to product sales, marketing, manufacturing and distribution.
Previous wording
Commercial Manufacturing and Supply Agreement with Lonza
Current wording
Commercial Manufacturing and Supply Agreement
Previous wording
On September 28, 2023, we and Sutro Biopharma amended certain terms of the Sutro Biopharma License Agreement, including with respect to (i) royalty reduction provisions applicable in the event of expiration of relevant patent claims, which would result in lower royalties payable by us to Sutro Biopharma under certain circumstances, (ii) the ownership, prosecution, maintenance and enforcement of certain intellectual property rights licensed or arising under the Sutro Biopharma License Agreement (including as agreed to be amended in the Option Agreement (as defined below)), and (iii) the timing and form for financial reporting of royalty payment calculations.
Current wording
In September 2023, we and Sutro Biopharma amended certain terms of the Sutro Biopharma License Agreement, including with respect to (i) royalty reduction provisions applicable in the event of expiration of relevant patent claims, which would result in lower royalties payable by us to Sutro Biopharma under certain circumstances, (ii) the ownership, prosecution, maintenance and enforcement of certain intellectual property rights licensed or arising under the Sutro Biopharma License Agreement (including as agreed to be amended in the Option Agreement (as defined below)), and (iii) the timing and form for financial reporting of royalty payment calculations.
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 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.
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
Previous wording
We operate in an industry that is subject to significant government regulation. Our operations are subject to significant risk and uncertainties, including financial, operational, technological, regulatory and political risks. Such factors include, but are not necessarily limited to, the results of clinical testing and trial activities; our ability to adequately demonstrate sufficient safety, tolerability and immunogenicity or efficacy of our vaccine candidates; our ability to enroll subjects in our ongoing and future clinical trials; our ability to successfully manufacture and supply our vaccine candidates for clinical trials or for future potential commercialization; our ability to obtain additional capital to finance our operations; our ability to obtain, maintain and protect our intellectual property rights; developments relating to our competitors and our industry, including competing vaccine candidates; the ability to obtain regulatory approval; the necessary requirements for regulatory approval; the ability to obtain favorable licensing, manufacturing or other agreements; the political and regulatory environment with the change in the U.S. administration in 2025; general and market conditions; and other risks and uncertainties, including those more fully described in the “Risk Factors” section of this Quarterly Report on Form 10-Q.
Current wording
We operate in an industry that is subject to significant government regulation. Our operations are subject to significant risk and uncertainties, including financial, operational, technological, regulatory and political risks. Such factors include, but are not necessarily limited to, the results of clinical testing and trial activities; our ability to adequately demonstrate sufficient safety, tolerability and immunogenicity or efficacy of our vaccine candidates; our ability to enroll subjects in our ongoing and future clinical trials; our ability to successfully manufacture and supply our vaccine candidates for clinical trials or for future potential commercialization; our ability to obtain additional capital to finance our operations; our ability to obtain, maintain and protect our intellectual property rights; developments relating to our competitors and our industry, including competing vaccine candidates; the ability to obtain regulatory approval; the necessary requirements for regulatory approval; the ability to obtain favorable licensing, manufacturing or other agreements; the political and regulatory environment; general and market conditions; and other risks and uncertainties, including those more fully described in the “Risk Factors” section of this Quarterly Report on Form 10-Q.
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 at this time while remaining confident in their potential and preserving the option to advance the programs in the future. 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. 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.
Previous wording
We expect our research and development expenses to increase in absolute dollars for the foreseeable future as we advance our vaccine candidates into and through preclinical studies and clinical trials, manufacture drug product for our clinical trials, scale up our manufacturing activities, establish additional manufacturing capacity to meet potential incremental supply requirements following the potential commercial launches of VAX-31 for adults in the adult population and VAX-31 or VAX-24 in the pediatric population, pursue regulatory approval of our vaccine candidates and expand our pipeline of vaccine candidates. The process of conducting the necessary preclinical and clinical research and completing the manufacturing requirements to obtain regulatory approval is costly and time-consuming. The actual probability of success for our vaccine candidates may be affected by a variety of factors, including the safety and efficacy or immunogenicity of our vaccine candidates, clinical data, investment in our clinical programs, competition, manufacturing capabilities and commercial viability. We may never succeed in achieving regulatory approval for any of our vaccine candidates. As a result of the uncertainties discussed above, we are unable to determine the duration and completion costs of our research and development projects or if, when and to what extent we will generate revenue from the commercialization and sale of our vaccine candidates.
Current wording
We expect our research and development expenses to increase in absolute dollars for the foreseeable future as we advance our vaccine candidates into and through preclinical studies and clinical trials, manufacture drug product for our clinical trials and to support the potential initial commercial launch of VAX-31 in the adult population, scale up our manufacturing activities, establish additional manufacturing capacity to meet potential incremental supply requirements following the potential commercial launches of VAX-31 in the adult population and VAX-31 or VAX-24 in the pediatric population, pursue regulatory approval of our vaccine candidates and expand our pipeline of vaccine candidates. The process of conducting the necessary preclinical and clinical research and completing the manufacturing requirements to obtain regulatory approval is costly and time-consuming. The actual probability of success for our vaccine candidates may be affected by a variety of factors, including the safety and efficacy or immunogenicity of our vaccine candidates, clinical data, investment in our clinical programs, competition, manufacturing capabilities and commercial viability. We may never succeed in achieving regulatory approval for any of our vaccine candidates. As a result of the uncertainties discussed above, we are unable to determine the duration and completion costs of our research and development projects or if, when and to what extent we will generate revenue from the commercialization and sale of our vaccine candidates.
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 and nine months ended September 30, 2025 and September 30, 2024. A grant receivable of $0.4 million and $0.4 million representing unreimbursed, eligible costs incurred under the agreements was recorded and included in Prepaid expenses and other current assets in the condensed consolidated balance sheets as of September 30, 2025 and December 31, 2024, respectively.
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 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.
Previous wording
Comparison of the Three and Nine Months Ended September 30, 2025 and 2024
Current wording
Comparison of the Three Months Ended March 31, 2026 and 2025
Previous wording
Research and development expenses increased by $93.0 million, or 79.5%, during the three months ended September 30, 2025 compared to the corresponding period in 2024. The increase was driven by external costs, which grew by $79.0 million largely due to increased development and manufacturing activities in connection with the adult and infant PCV programs and to support the potential future commercial launches. Product manufacturing costs increased by $69.4 million, clinical costs increased by $5.2 million, research and development consumables, facility allocated costs increased by $2.1 million compared to the prior period, and lab supplies and equipment increased by $1.3 million compared to the prior period. The increase was further driven by internal personnel-related costs, which grew by $14.0 million largely due to headcount growth.
Current 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.
Previous wording
Other income, net decreased by $7.3 million, or 19.7%, during the three months ended September 30, 2025 compared to the corresponding period in 2024. The decrease was primarily attributable to an $8.3 million reduction in unrealized and realized foreign currency gains due to fluctuations in the foreign currency exchange rates.
Current 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.
Previous wording
From inception through September 30, 2025, 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 $4.7 billion in aggregate gross proceeds and $4.5 billion net of underwriting discounts, commissions and offering expenses. As of September 30, 2025, we had $0.3 billion in cash and cash equivalents, $2.4 billion in investments and an accumulated deficit of $1.9 billion.
Current 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.
Previous wording
In July 2021, we entered into an Open Market Sales Agreement SM (the “Original ATM Sales Agreement”) with Jefferies LLC (“Jefferies”), which provided that, upon the terms and subject to the conditions and limitations set forth in the Original ATM Sales Agreement, we had the right to issue and sell, from time to time, shares of our common stock having an aggregate offering price of up to $150.0 million through Jefferies acting as our sales agent or principal. As of February 27, 2023, we had sold 4,995,709 shares of our common stock under the Original ATM Sales Agreement at a weighted average price of $27.57 per share for aggregate gross proceeds of $137.8 million. On February 27, 2023, we and Jefferies entered into an amendment to the Original ATM Sales Agreement (as amended, the “Amended ATM Sales Agreement”) pursuant to which we may offer and sell shares of our common stock having an aggregate offering price of up to $400.0 million. The material terms and conditions of the Original ATM Sales Agreement otherwise remain unchanged. We will pay Jefferies a commission of up to 3.0% of the gross sales proceeds of any common stock sold through Jefferies under the Amended ATM Sales Agreement; however, we are not obligated to make any sales of common stock. As of September 30, 2025, we have sold 4,211,367 shares of our common stock under the Amended ATM Sales Agreement at a weighted average price of $64.19 per share for aggregate gross proceeds of $270.3 million ($264.2 million net of commissions and offering expenses) with $129.7 million remaining for future sales under the Amended ATM Sales Agreement. We have made no sales under the Amended ATM Sales Agreement since August 2024.
Current wording
In July 2021, we entered into an Open Market Sales Agreement SM (the “Original ATM Sales Agreement”) with Jefferies LLC (“Jefferies”), which provided that, upon the terms and subject to the conditions and limitations set forth in the Original ATM Sales Agreement, we had the right to issue and sell, from time to time, shares of our common stock having an aggregate offering price of up to $150.0 million through Jefferies acting as our sales agent or principal. As of February 27, 2023, we had sold 4,995,709 shares of our common stock under the Original ATM Sales Agreement at a weighted average price of $27.57 per share for aggregate gross proceeds of $137.8 million. On February 27, 2023, we and Jefferies entered into an amendment to the Original ATM Sales Agreement (as amended, the “Amended ATM Sales Agreement”) pursuant to which we had the right to issue and sell, from time to time, shares of our common stock having an aggregate offering price of up to $400.0 million. Effective as of February 24, 2026, we terminated the Amended ATM Sales Agreement. Prior to termination, we sold 4,211,367 shares of our common stock under the Amended ATM Sales Agreement at a weighted average price of $64.19 per share for aggregate gross proceeds of $270.3 million ($264.2 million net of commissions and offering expenses).
Previous wording
The pre-funded warrants are exercisable, at the option of each holder, in whole or in part by delivering to us a duly executed exercise notice and payment of the exercise price. No fractional shares of common stock will be issued in connection with the exercise of a pre-funded warrant. The holders of the pre-funded warrants may also satisfy their obligation to pay the exercise price through a “cashless exercise,” in which the holder receives the net value of the pre-funded warrant in shares of common stock determined according to the formula set forth in the pre-funded warrant.
Current wording
From January 2022 through September 2024, we successfully completed a number of underwritten public offerings, which included pre-funded warrants to purchase a total of 10,458,434 shares of our common stock. The pre-funded warrants are exercisable, at the option of each holder, in whole or in part by delivering to us a duly executed exercise notice and payment of the exercise price. Each pre-funded warrant has an exercise price of $0.001 per share. No fractional shares of common stock will be issued in connection with the exercise of a pre-funded warrant. The holders of the pre-funded warrants may also satisfy their obligation to pay the exercise price through a “cashless exercise,” in which the holder receives the net value of the pre-funded warrant in shares of common stock determined according to the formula set forth in the pre-funded warrant.
Previous wording
In January 2025, 1,000,000 shares and 2,500,000 shares underlying the pre-funded warrants from the January 2022 and October 2022 offerings, respectively, were exercised to receive 999,988 shares and 2,499,971 shares of common stock, net of exercise costs, respectively. In June 2025, 640,705 shares underlying pre-funded warrants from the February 2024 offering were exercised to receive 640,685 shares of common stock, net of exercise costs. As of September 30, 2025, no other shares underlying the pre-funded warrants have been exercised.
Current 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.
Previous wording
In February 2024, we completed an underwritten public offering of 12,695,312 shares of our common stock, which included the full exercise of the underwriters’ option to purchase an additional 1,757,812 shares, at a price of $64.00 per share and pre-funded warrants to purchase 781,250 shares of our common stock at a price of $63.999 per underlying share. In aggregate, we received $816.5 million in net proceeds after deducting underwriting discounts and commissions and other offering expenses payable by us, and excluding the exercise of any pre-funded warrants.
Current wording
In February 2026, we completed an underwritten public offering of 12,650,000 shares of our common stock, which included the full exercise of the underwriters’ option to purchase an additional 1,650,000 shares, at a price of $50.00 per share. In aggregate, we received $601.8 million in net proceeds after deducting underwriting discounts, commissions and other offering expenses payable by us.
Previous wording
Net cash used in operating activities for the nine months ended September 30, 2025 was $430.7 million, an increase of $89.5 million compared to the nine months ended September 30, 2024. 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 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.
Previous wording
Net cash provided by investing activities for the nine months ended September 30, 2025 was $322.2 million, an increase of $1.8 billion compared to net cash used in investing activities for the nine months ended September 30, 2024. The change was primarily attributable to a $1.4 billion decrease in purchases of investments, $377.5 million increase in maturities and sales of investments, and a $40.6 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 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.
Previous wording
Net cash used in financing activities for the nine months ended September 30, 2025 was $0.4 million, a decrease of $2.4 billion compared to the cash provided by financing activities for nine months ended September 30, 2024. The decrease was primarily due to the proceeds from a follow-on offering as well as at-the-market offerings during the nine months ended September 30, 2024, whereas no such offerings occurred during the nine months ended September 30, 2025.
Current 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.
Previous wording
We have operating lease agreements for our office spaces. As of September 30, 2025, we had total lease payment obligations of $117.9 million, of which $11.5 million is payable within one year.
Current 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.
Previous wording
On November 21, 2023 (the “Option Exercise Date”), we exercised the Option pursuant to the Option Agreement by submitting written notice thereof to Sutro Biopharma and concurrently paid Sutro Biopharma $50.0 million in cash as the first of two installment payments for the Option exercise price. In May 2024, we paid the second and final installment of $25.0 million in cash for the Option exercise. Upon the occurrence of certain regulatory milestones, we would be obligated to pay Sutro Biopharma certain additional milestone payments totaling up to $60.0 million in cash. In the event that we undergo a change of control, certain rights and payments may be accelerated.
Current wording
In November 2023 (the “Option Exercise Date”), we exercised the Option pursuant to the Option Agreement by submitting written notice thereof to Sutro Biopharma and paid Sutro Biopharma an aggregate of $75.0 million in cash for the Option exercise price, with the final payment made in May 2024. Upon the occurrence of certain regulatory milestones, we would be obligated to pay Sutro Biopharma certain additional milestone payments totaling up to $60.0 million in cash. In the event that we undergo a change of control, certain rights and payments may be accelerated.
Rearranged current paragraphs (4)
Current report — wording carried from elsewhere
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 report — wording carried from elsewhere
▪The modified study is evaluating the safety, tolerability and immunogenicity of VAX-31 and compared to PCV20 in 900 participants, including the 100 participants previously enrolled in the Low Dose arm.
Current report — wording carried from 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.
Current report — wording carried from 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.
Rearranged previous paragraphs (9)
Previous report — wording carried elsewhere
•In August 2025, we announced that the FDA expanded the BTD for VAX-31 to include the prevention of pneumonia caused by Streptococcus pneumoniaein adults.
Previous report — wording carried elsewhere
•In February 2025, we announced that the Phase 2 randomized, dose-finding study of VAX-31 in healthy infants had advanced to the second stage of the study.
Previous report — wording carried elsewhere
•Reported Final VAX-24 Infant Phase 2 Dose-Finding Study Data Consistent with Previously Reported Positive Interim Data: In November 2025, we announced the final safety, tolerability, and immunogenicity results from the VAX-24 infant Phase 2 study, which were consistent with the positive interim data reported in March 2025. The final data analysis included full 6-month safety results and complete post-dose 3 (primary immunization series) and post-dose 4 (booster dose) IgG and OPA results.
Previous report — wording carried elsewhere
In this study, VAX-24 was well-tolerated and demonstrated a safety profile similar to PCV20 across all doses studied. Post-dose 3 and post-dose 4, all VAX-24 doses evaluated (Low: 1.1 mcg, Mid: 2.2mcg and Mixed: 2.2mcg/4.4mcg) demonstrated robust IgG and OPA immunogenicity responses.
Previous report — wording carried elsewhere
Post-dose 3, all VAX-24 doses met target precedent Phase 2 non-inferiority criteria on relative seroconversion rates (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 serotype) for the highest circulating serotypes contained in VAX-24.The Low and Mid doses met the non-inferiority 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 >0.6 for 21 of 24 serotypes.
Previous report — wording carried elsewhere
Post-dose 4, all VAX-24 doses met our 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.
Previous report — wording carried elsewhere
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.
Previous report — wording carried elsewhere
Amended and Restated License Agreement with Sutro Biopharma
Previous report — wording carried elsewhere
$2.9 million compared to the prior period The increase was further driven by internal personnel-related costs, which grew by $53.1 million largely due to headcount growth.