Vaxcyte, Inc.

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 the fourth quarter of 2025 and announce topline safety, tolerability and immunogenicity data from this study in 2026. We plan to initiate the remaining Phase 3 studies in 2025 and 2026 and announce data from those studies in 2026 and 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 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.

Previous wording

•In November 2024, we announced that the 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 a breakthrough therapy designation ("BTD") for VAX-31 for the prevention of IPD in adults.

Previous wording

•In March 2025, we announced positive topline data from the VAX-24 infant Phase 2 dose-finding study evaluating the safety, tolerability and immunogenicity of VAX-24 compared to PCV20 in healthy infants. In this study, VAX-24 was well-tolerated and demonstrated a safety profile similar to PCV20 across all doses studied.

Current wording

•In March 2025, we announced positive topline, interim data from the VAX-24 infant Phase 2 study, a randomized, observer-blind, dose-finding two-stage clinical study evaluating the safety, tolerability and immunogenicity of VAX-24 in healthy infants that enrolled 803 participants.

Previous wording

◦Post-dose 3, the VAX-24 Mid dose met target precedent Phase 2 non-inferiority criteria (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), particularly for the highest circulating serotypes contained in VAX-24 and for 20 of 24 serotypes overall.

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 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 wording

•An interim assessment of the IgG results was performed with available study samples at 1-month post-dose 4 (booster dose) and demonstrated that the Mid dose met our historical target Phase 2 IgG GMR point estimate of >0.6 for the highest circulating serotypes contained in VAX-24 and for 19 of 24 serotypes overall. Additionally, VAX-24 elicited robust memory responses across all doses for all serotypes, as evidenced by the boost demonstrated post-dose 4 for IgG responses relative to post-dose 3 IgG responses.

Current wording

•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 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 and final stage of the study.

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.

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. Both the Middle dose and High dose VAX-31 arms in the study will proceed, while we have elected to discontinue enrollment in the Low dose arm.

Current 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.

Previous wording

•The modified study will evaluate 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. 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. We expect to proceed with the modified Phase 2 randomized, dose-finding study by the end of the third quarter of 2025.

Current 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.

Previous wording

•We expect to announce topline safety, tolerability and immunogenicity data for the Phase 2 randomized, dose-finding study from both the primary three-dose immunization series and booster dose by the end of the first half of 2027.

Current 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.

Previous wording

•All VAX-24 doses evaluated (Low: 1.1 mcg, Mid: 2.2mcg and Mixed: 2.2mcg/4.4mcg) elicited substantial IgG and OPA immune responses at 1-month post-dose 3 (primary immunization series):

Current wording

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 wording

•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 the fourth quarter of this year, with topline data expected in 2026, consistent with prior readout guidance. Initiation of the remaining Phase 3 studies, which are shorter in duration than the non-inferiority study, is planned for 2025 and 2026. The VAX-31 High dose (all serotypes dosed at 3.3mcg or 4.4mcg) has been selected to advance into Phase 3. Subject to the results of the Phase 3 studies, which are expected to read out in 2026 and 2027, we plan to submit a BLA shortly following the completion of the last Phase 3 study.

Current wording

•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 wording

VAX-31 Optimized dose with the majority of serotypes dosed at 4.4mcg and the balance dosed at 3.3mcg. Both the Middle dose and High dose VAX-31 arms in the study will proceed, while we have elected to discontinue enrollment in the Low dose arm. The modified study will evaluate VAX-31 in approximately 900 participants, including the 100 participants previously enrolled in the Low dose arm. Enrollment in the modified study is expected to proceed by the end of the third quarter of this year with topline data from both the primary immunization series and the booster dose by the end of the first half of 2027.

Current wording

•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 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 $166.6 million and $307.3 million for the three and six months ended June 30, 2025, respectively. As of June 30, 2025, we had an accumulated deficit of $1.7 billion and cash, cash equivalents and investments of $2.8 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 $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.

Previous wording

Commercial Manufacturing and Supply Agreement

Current wording

Commercial Manufacturing and Supply Agreement with Lonza

Previous wording

On October 13, 2023, we entered into a pre-commercial services and commercial manufacturing supply agreement with Lonza (the “Commercial Manufacturing and Supply Agreement”).

Current wording

On October 13, 2023, we entered into a pre-commercial services and commercial manufacturing supply agreement with Lonza (the “Lonza Commercial Manufacturing and Supply Agreement”).

Previous wording

Pursuant to the 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 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).

Previous wording

Under the 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 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 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.

Previous wording

Unless earlier terminated, the Commercial Manufacturing and Supply 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 (with 24 months advanced notice to Lonza). We are permitted to terminate the Commercial Manufacturing and Supply Agreement for convenience or for Lonza’s uncured material breach, in each case subject to certain notice obligations. Lonza is permitted to terminate the Commercial Manufacturing and Supply Agreement in the event that we commit certain specified material breaches, including uncured failure to pay material and undisputed amounts of money due to Lonza, subject to certain notice obligations. Either party may terminate the Commercial Manufacturing and Supply Agreement in certain circumstances in the event of the other party’s bankruptcy. In the event that we terminate the agreement for convenience, or Lonza terminates the agreement in the event that we commit certain specified material breaches, then certain termination consequences may be triggered, including that (i) we would forfeit any outstanding entitlement to credit from Lonza of the Repurposing Fee (as defined below), and (ii) we would be obligated to pay Lonza a termination penalty equal to the greater of (a) CHF 70.0 million, or (b) a prespecified number of months’ FTE fees for the actual FTEs assigned to us as of the date of termination. Within 30 days of the Effective Date, we paid Lonza a repurposing fee (the “Repurposing Fee”) of CHF 27.0 million that will be credited back to us over a 10-year period starting upon commencement of commercial production. In the event of termination under certain circumstances, Lonza shall be obligated to provide certain wind-down and transition services to us for up to 12 and 24 months, respectively.

Current wording

Unless earlier terminated, the Lonza Commercial Manufacturing and Supply 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 (with 24 months advanced notice to Lonza). We are permitted to terminate the Lonza Commercial Manufacturing and Supply Agreement prior to expiration, subject to applicable termination fees. Within 30 days of the Effective Date, we paid Lonza a repurposing fee (the “Repurposing Fee”) of CHF 27.0 million that will be credited back to us over a 10-year period starting upon commencement of commercial production.

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 six months ended June 30, 2025 and June 30, 2024. A grant receivable of $0.1 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 June 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 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.

Previous wording

Comparison of the Three and Six Months Ended June 30, 2025 and 2024

Current wording

Comparison of the Three and Nine Months Ended September 30, 2025 and 2024

Previous wording

Research and development expenses increased by $62.7 million, or 47.7%, during the three months ended June 30, 2025 compared to the corresponding period in 2024. The increase was driven by external costs, which grew by $43.0 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 $25.6 million, clinical costs increased by $3.1 million, research and development consumables, lab supplies and equipment increased by $9.6 million, and facility and allocated costs increased by $3.5 million compared to the prior period. The increase was further driven by internal personnel-related costs, which grew by $19.7 million largely due to headcount growth.

Current 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.

Previous wording

Research and development expenses increased by $116.2 million, or 51.4%, during the six months ended June 30, 2025 compared to the corresponding period in 2024. The increase was driven by external costs, which grew by $77.1 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 $52.9 million, research and development consumables, lab supplies and equipment increased by $16.0 million, facility and allocated costs increased by $7.6 million, and other external costs increased by $3.0 million, which were partially offset by a decrease of

Current wording

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 wording

$2.3 million in clinical costs due to reduced clinical trial activities compared to the prior period. The increase was further driven by internal personnel-related costs, which grew by $39.1 million largely due to headcount growth.

Current wording

$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.

Previous wording

General and administrative expenses increased by $10.6 million, or 49.2%, during the three months ended June 30, 2025 compared to the corresponding period in 2024. The increase was primarily attributable to higher personnel-related costs, largely due to headcount growth.

Current wording

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 wording

General and administrative expenses increased by $23.3 million, or 56.4%, during the six months ended June 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, professional services costs related to corporate affairs activities.

Current wording

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 wording

Other income, net increased by $56.0 million, or 128.0%, during the six months ended June 30, 2025 compared to the corresponding period in 2024. The increase was primarily attributable to a $38.5 million increase in unrealized and realized foreign currency gains due to the weakening of the US Dollar relative to the Swiss Franc, an $18.5 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.

Current wording

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 wording

From inception through June 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 June 30, 2025, we had $0.3 billion in cash and cash equivalents, $2.5 billion in investments and an accumulated deficit of $1.7 billion.

Current 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.

Previous wording

Net cash used in operating activities for the six months ended June 30, 2025 was $287.4 million, an increase of $6.9 million compared to the six months ended June 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 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.

Previous wording

Net cash provided by investing activities for the six months ended June 30, 2025 was $201.1 million, an increase of $732.5 million compared to net cash used in investing activities for the six months ended June 30, 2024. The change was primarily attributable to a $343.2 million increase in maturities and sales of investments, a $374.8 million decrease in purchases of investments, and a $14.5 million decrease in purchases of property and equipment, manufacturing facility build-out and equipment construction-in-progress.

Current 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.

Previous wording

Net cash provided by financing activities for the six months ended June 30, 2025 was $3.3 million, a decrease of $925.3 million compared to the six months ended June 30, 2024. The decrease was primarily due to the proceeds from a follow-on offering as well as at-the-market offerings during the six months ended June 30, 2024, whereas no such offerings occurred during the six months ended June 30, 2025.

Current 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.

Previous wording

We have operating lease agreements for our office spaces. As of June 30, 2025, we had total lease payment obligations of $120.9 million, of which $11.8 million is payable within one year.

Current 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.