What changed in this filing

/stocks — the workspaceLOADING

Item 1. Business

2026-02-24 compared with 2025-02-25 · 338 added, 334 removed, 858 unchanged (44% of the section changed)

We are a clinical-stage vaccine innovation company engineering high-fidelity vaccines 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.

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.

Vaccines are one of the most successful and cost-effective global health interventions and prevent millions of deaths worldwide each year.

Routine pediatric vaccinations in the United States are estimated to prevent approximately 17 million cases of disease each year, and it is estimated that every $1 spent on childhood vaccination results in savings of approximately $11.

Adult vaccination rates are lower than pediatric vaccination rates, but new technologies are driving adult vaccine development, which in turn is fueling the growth of the overall vaccine market.

Given the critical role vaccines play in preventing disease from childhood to adulthood, the global vaccine market is large, durable and growing.

Routine pediatric vaccinations in the United States are estimated to prevent approximately 17 million cases of disease over the lifetimes of each annual birth cohort, and it is estimated that every $1 spent on childhood vaccination results in savings of approximately $11.

Adult vaccination has increased with the introduction of new vaccines along with expanded age recommendations and growing international adoption, which is contributing to the growth of the overall vaccine market.

Given the critical role vaccines play in preventing disease from childhood through adulthood, the global vaccine market is large, durable and growing.

There are areas of significant unmet medical need, including vaccines that can provide broader protection, against both currently circulating and historically prevalent strains, than currently marketed vaccines and novel vaccines that target pathogens for which there are no currently approved vaccines.

4 unchanged sentences

Our pipeline includes:

• 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 is an infection caused by Streptococcus pneumoniae bacteria.

It can result in invasive pneumococcal disease (“IPD”), including meningitis and bacteremia, and non-invasive pneumococcal disease, including pneumonia, otitis media and sinusitis.

Our broad-spectrum, carrier-sparing PCV candidates, VAX-31 and VAX-24, are designed to improve upon the 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.

• 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.

◦ PCV Franchise Adult Indication:

▪ VAX-31 is a 31-valent, broad-spectrum, carrier-sparing investigational PCV being developed for the prevention of IPD.

▪ 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 more than 95% of IPD circulating in adults in the United States aged 50 and older, with the potential to provide an incremental 12-40% of coverage over current standard-of-care adult PCVs.

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.

• In September 2024, we announced positive topline results from a Phase 1/2 study of VAX-31 in adults.

1 unchanged sentence

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.

The Phase 1 portion of the study included 64 healthy adults 50 to 64 years of age and the Phase 2 portion included 951 healthy adults 50 years of age and older.

The immunogenicity objectives of the study

included an assessment of the induction of antibody responses at Month 1, based on opsonophagocytic activity (“OPA”) and immunoglobulin G ("IgG"), at each of the three VAX-31 doses and compared to PCV20 for the 20 serotypes in common, as well as for the additional 11 serotypes contained in VAX-31, but not in PCV20.

The Phase 1 portion of the study included 64 healthy adults 50 to 64 years of age and the Phase 2 portion included

951 healthy adults 50 years of age and older.

The immunogenicity objectives of the study included an assessment of the induction of antibody responses at Month 1, based on opsonophagocytic activity (“OPA”) and immunoglobulin G ("IgG"), at each of the three VAX-31 doses and compared to PCV20 for the 20 serotypes in common, as well as for the additional 11 serotypes contained in VAX-31, but not in PCV20.

In the Phase 1/2 study, VAX-31 was observed to be well tolerated and demonstrated a safety profile at all doses studied through the full six-month evaluation period similar to PCV20.

5 unchanged sentences

For all 11 incremental serotypes unique to VAX-31, and not in PCV20, all three doses met the superiority criteria.

Based on these positive results, we selected VAX-31 to advance to an adult Phase 3 program, and plan to select the dose prior to the initiation of such program.

Following an FDA End-of-Phase 2 meeting, we plan to initiate a Phase 3 pivotal, non-inferiority study by mid-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.

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

Based on these positive results, we selected the High Dose of VAX-31 to advance to an adult Phase 3 program.

• In November 2024, we announced that the 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 .

• 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 evaluating VAX-31 for the prevention of IPD and pneumonia in adults compared to standard-of-care PCVs ("OPUS-1").

We expect to announce topline safety, tolerability and immunogenicity data from this study in the fourth quarter of 2026.

• 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”).

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).

◦ PCV Franchise Pediatric Indication:

▪ VAX-24 is a 24-valent, broad-spectrum, carrier-sparing investigational PCV being developed for the prevention of IPD in infants, and it covers more serotypes than any pneumococcal infant vaccine on the market today.

• In March 2023, we announced that the first participants were dosed in the first stage of a Phase 2 study of VAX-24 in healthy infants.

The Phase 2 infant study is being conducted in two stages and compares VAX-24 to the broadest-spectrum standard-of-care PCVs currently available.

Stage 1 of the study evaluated the safety and tolerability of a single injection of VAX-24 at three dose levels, 1.1mcg, 2.2mcg and 2.2mcg/4.4mcg, and compared to VAXNEUVANCE TM (“PCV15”), the broadest-spectrum standard-of-care PCV at that time, in 48 infants in a dose-escalation approach.

• In July 2023, we announced that the Phase 2 study of VAX-24 in healthy infants had advanced to the second and final stage of the study.

An independent data safety monitoring board ("DSMB") approved advancing to the second stage of the study following the review of the safety and tolerability results from the first stage.

Additionally, in agreement with the FDA, we amended the study protocol for Stage 2 of the study, changing the study comparator to PCV20, which became the broadest-spectrum PCV recommended by the Advisory Committee on Immunization Practices (“ACIP”) in June 2023.

This Phase 2 study is evaluating the safety, tolerability and immunogenicity of VAX-24 in healthy infants at the same three dose levels, 1.1mcg, 2.2mcg and 2.2mcg/4.4mcg, that were evaluated in Stage 1.

Per ACIP guidelines, the primary immunization series includes three doses given at two months, four months and six months of age, followed by a booster dose at 12-15 months of age.

• In March 2024, we announced the completion of enrollment in the VAX-24 Phase 2 study in infants.

A total of 802 healthy infants (48 from stage 1 and 754 from Stage 2) were enrolled.

We expect to announce topline safety, tolerability and immunogenicity

data from the Phase 2 primary three-dose immunization series by the end of the first quarter 2025, followed by topline data from the booster dose by the end of 2025.

▪ 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 94% of IPD and 93% of acute otitis media due to streptococcus pneumonia in children under five years of age in the United States .

• In December 2024, we announced that the first participants were dosed in the first stage of a Phase 2 study of VAX-31 in infants.

▪ 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.

▪ 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.

• In February 2025, we announced that the Phase 2 study of VAX-31 in healthy infants had advanced to the second and final 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 approximately 750 infants.

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 continued the standard dosing regimen as part of Stage 2.

▪ 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.

We expect to share topline data from the primary three-dose immunization series of the study in mid-2026, followed by topline data from the booster dose approximately nine months later.

▪ 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 enrollment in the Low Dose arm.

The Middle and High Dose arms continued as planned.

▪ 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.

▪ 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.

▪ 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.

• 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.

• 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.

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 demonstrated robust IgG and OPA immunogenicity responses.

• 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.

• 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.

• 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.

• The final positive data from the VAX-24 infant Phase 2 dose-finding study further validated our rationale for exploring higher doses in the ongoing VAX-31 infant Phase 2 study.

◦ VAX-XL is a third-generation PCV candidate designed to provide the broadest coverage of any PCV currently in development.

• VAX-A1, a novel conjugate vaccine candidate designed to prevent disease caused by Group A Streptococcus (“Group A Strep”).

2 unchanged sentences

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.

We continue to advance the development of VAX-A1 and we intend to provide further information about the anticipated timing of an IND application as the program progresses.

• VAX-PG, a novel protein vaccine candidate targeting the keystone pathogen responsible for periodontitis, a chronic oral inflammatory disease affecting an estimated 65 million adults in the United States.

We believe we have generally demonstrated preclinical proof of concept for a periodontitis protein vaccine, the data for which was published in February 2019.

We nominated a final vaccine candidate for VAX-PG in 2022 and are conducting large-animal confirmatory studies prior to advancing the program to potential IND-enabling activities.

Our initial goal is to develop a therapeutic vaccine to slow or stop disease progression;

however, the results from clinical trials may inform the potential adoption of prophylactic immunization.

We plan to initiate a Phase 1 adult study for VAX-A1 in 2026, with the primary objective of assessing safety and tolerability.

• VAX-GI, a novel preclinical vaccine candidate being developed as a preventative treatment for dysentery and shigellosis, which is caused by Shigella bacteria.

3 unchanged sentences

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.

• Other discovery-stage programs that leverage our cell-free protein synthesis platform, which, if proven successful in preclinical studies, could also be advanced into IND-enabling activities and clinical studies.

Our modern synthetic techniques, including advanced chemistry and the XpressCF™ cell-free protein synthesis platform, offer several advantages over conventional cell-based protein expression methods, which we believe enable us to generate

superior, novel, broader-spectrum and/or more immunogenic vaccines.

In the context of conjugate vaccines, we believe we can add more antigenic strains without compromising the overall immune response.

In particular, our ability to specify the attachment point of antigens, including polysaccharides, on protein carriers represents a significant improvement over the random conjugation that occurs with conventional technologies.

This site-specific conjugation is designed to ensure that B-cell and/or T-cell epitopes are optimally exposed, maximizing the immune response, whereas random conjugation blocks these critical immunogenic epitopes, which dampens the immune response and may lead to a phenomenon known as carrier suppression.

We believe this precise control of conjugation chemistry enables us to design broader-spectrum conjugate vaccine candidates using carrier-sparing conjugates that use less protein carrier without sacrificing immunogenicity.

We are also able to design novel conjugate vaccine candidates using standard amounts of protein carrier to generate heightened immunogenicity.

Beyond conjugate vaccines, we believe we can also design novel protein vaccine candidates based on well-appreciated but highly complex antigens that currently cannot be made using conventional technologies to address diseases for which there are no available vaccines.

In addition, our platform enables us to rapidly screen vaccine candidates, requiring less effort than conventional chemistry which allows us to produce and iterate conjugate candidates, thereby dramatically accelerating the development cycle of designing, producing and testing vaccine candidates.

To address areas of significant unmet medical need, we carefully select the disease areas we target and are developing vaccine candidates based on the following criteria:

1 unchanged sentence

We select vaccine targets that are characterized by an established patient population and significant unmet medical need.

Our PCV candidates, VAX-31 and VAX-24, are designed to improve upon the standard-of-care 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.

We believe that by providing the broadest coverage of serotypes for PCVs, as well as providing novel vaccines for diseases for which there are no currently approved vaccines, we can leverage the U.S.

Our PCV candidates are designed to improve upon the standard-of-care 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.

We believe that by providing the broadest coverage of serotypes for PCVs, as well as providing novel vaccines for diseases for which there are no currently approved vaccines, we can leverage the

Centers for Disease Control (“CDC”), ACIP and similar international advisory body recommendations to drive rapid and significant market adoption.

7 unchanged sentences

For our novel vaccine candidates, for which we believe clinical field efficacy studies will be necessary, we select disease areas with high attack rates, such as Group A Strep, which may allow for more manageable study sizes.

For novel protein-based therapeutic vaccine candidates, such as our periodontitis vaccine candidate, we select disease areas for which we believe clinical efficacy may be evaluated based on disease progression rather than prevention, which could allow for smaller and faster trials relative to preventative vaccines.

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 to develop potentially superior and novel conjugate and protein vaccine candidates for adult and pediatric indications using the above criteria by taking advantage of the following:

In the context of conjugate vaccines, we believe we can add more antigenic strains without compromising the overall immune response.

We are also able to design novel conjugate vaccine candidates using standard amounts of protein carrier to generate heightened immunogenicity.

We are re-engineering the way highly complex vaccines are made to develop potentially superior and novel conjugate and protein vaccine candidates for adult and pediatric indications using the above criteria by taking advantage of the following:

• Site-specific conjugation.

We are able to specify the attachment point of antigens, including polysaccharides, on protein carriers to ensure optimal exposure of B-cell and/or T-cell epitopes, thereby creating protein carriers designed to have enhanced potency.

We believe this precise control of conjugation chemistry enables us to create broader-spectrum conjugate vaccine candidates using carrier-sparing conjugates that use less protein carrier

without sacrificing immunogenicity.

We believe this precise control of conjugation chemistry enables us to create broader-spectrum conjugate vaccine candidates using carrier-sparing conjugates that use less protein carrier without sacrificing immunogenicity.

We are also able to design novel conjugate vaccine candidates using standard amounts of protein carrier to generate heightened immunogenicity.

9 unchanged sentences

Key elements of our strategy include:

• Advance VAX-31 and VAX-24 through clinical development and regulatory approval.

Our PCV candidates, VAX-31 and VAX-24, target the pneumococcal vaccine market.

• Advance our PCV candidates through clinical development and regulatory approval.

Our PCV candidates, VAX-31,VAX-24 and VAX-XL, target the pneumococcal vaccine market.

We are advancing these PCV candidates along a well-understood clinical development pathway in an effort to obtain regulatory approval in adults and infants based on successful completion of clinical studies using previously established surrogate immune endpoints, without the need to conduct clinical field efficacy studies, consistent with how other conjugate vaccines have obtained approval.

◦ Adult Indication:

▪ Following the positive topline data from the VAX-31 adult Phase 1/2 study announced in September 2024, we selected VAX-31 to exclusively advance to an adult Phase 3 program, and plan to select the dose prior to the initiation of such program.

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 adult Phase 3 studies, we would expect to submit a Biologics License Application (“BLA”) for VAX-31 shortly following the completion of the last Phase 3 study.

◦ Pediatric Indication:

▪ In March 2024, we announced the completion of enrollment in the Phase 2 clinical study evaluating VAX-24 for the prevention of IPD in healthy infants.

We expect to announce topline safety, tolerability and immunogenicity data from the Phase 2 primary three-dose immunization series, which is fully enrolled with 802 healthy infants, by the end of the first quarter 2025, followed by topline data from the booster dose by the end of 2025.

▪ In December 2024, we announced the initiation of a Phase 2 clinical study evaluating VAX-31 for the prevention of IPD in healthy infants.

In February 2025, we announced that the Phase 2 study of VAX-31 in healthy infants had advanced to the second and final stage of the study.

We expect to announce topline data from the Phase 2 primary three-dose immunization series in mid-2026, followed by topline data from the booster dose approximately nine months later.

▪ Our Phase 3 and commercial strategy for VAX-24 and/or VAX-31 for the infant indication will depend on several factors, including the results from, and timing of, our ongoing Phase 2 studies for each program.

• Establish scalable production of VAX-31 and VAX-24.

• Establish scalable production of our PCV candidates.

We believe high-quality and scalable manufacturing is critical to our long-term success.

We have designed and developed a proprietary, scalable and portable manufacturing process that we have scaled to supply clinical volumes and believe can scale to supply initial

volumes of VAX-31 and VAX-24 needed to support commercial launch.

We have designed and developed a proprietary, scalable and portable manufacturing process that we have scaled to supply clinical volumes and believe can scale to supply initial volumes of VAX-31 needed to support commercial launch.

We have access to substantial manufacturing resources through our contract manufacturer, Lonza, that we believe can facilitate an independent path to market.

1 unchanged sentence

In October 2023, to complement this plan, we entered into a new commercial manufacturing agreement with Lonza to support the potential global commercialization of our PCV candidates in both the adult and pediatric populations.

In November 2023, we entered into a manufacturing rights agreement with Sutro Biopharma to obtain control over the development and manufacture of cell-free extract, a key component of our PCV franchise.

In November 2023, we entered into a manufacturing rights agreement with Sutro Biopharma, Inc ("Sutro Biopharma") to obtain control over the development and manufacture of cell-free extract, a key component of our PCV franchise.

Pursuant to the manufacturing rights agreement, we obtained exclusive rights to independently, or through certain third parties, develop, improve and manufacture cell-free extract for use in connection with our vaccine candidates.

In addition, 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.

• Create a long-lasting PCV franchise by offering the broadest-spectrum PCV available.

The two leading pneumococcal vaccine franchises to date, Prevnar and Pneumovax 23 (“PPSV23”), have been administered well over a billion times, generating over $100 billion in combined sales over 20 and 40 years, respectively, and can attribute their success to being the broadest-spectrum vaccines on the market.

If approved, we believe VAX-31 and VAX-24 may replace the standard-of-care PCVs currently available because of their potentially broader coverage against both currently circulating and historically prevalent strains.

The two leading pneumococcal vaccine franchises to date, Prevnar and Pneumovax 23 (“PPSV23”), have been administered well over a billion times, generating over $100 billion in combined sales over 20 and 40 years, respectively, and can attribute their success to having been the broadest-spectrum vaccines on the market.

In addition, the recently approved PCV, Capvaxive ® ("PCV21"), is now commercially available for the adult market.

If approved, we believe VAX-31 and/or VAX-24 may potentially replace the standard-of-care PCVs currently available because of their coverage against both currently circulating and historically prevalent strains.

We designed VAX-24 to address the 24 pneumococcal strains covered by Prevnar and PPSV23 that drive a significant portion of pneumococcal disease today with the durable, boostable immune response of a conjugate vaccine.

Further, we have designed VAX-31 to address these 24 strains plus seven additional epidemiologically significant emerging strains that are causing increasing pneumococcal disease and antibiotic resistance, which collectively drive most pneumococcal disease today.

With these broad-spectrum vaccine candidates, we believe we are well-positioned to obtain ACIP preferred recommendations and potentially replace the current standard-of-care for pneumococcal disease prevention in both adult and pediatric populations, thereby creating a long-lasting PCV franchise.

• Advance our novel vaccine candidates and leverage our platform to expand our pipeline.

◦ Advance VAX-A1 through IND-enabling activities, clinical development and regulatory approval .

With these broad-spectrum vaccine candidates, we believe we are well-positioned to obtain ACIP recommendations and potentially replace the current standard-of-care for pneumococcal disease prevention in both adult and pediatric populations, thereby creating a long-lasting PCV franchise.

• Develop novel vaccine candidates and leverage our platform to expand our pipeline.

We believe our data published in December 2020 demonstrated preclinical proof of concept for VAX-A1.

We nominated the final vaccine candidate and initiated IND-enabling activities for VAX-A1 in 2021.

We continue to advance the development of VAX-A1 and we intend to provide further information about the anticipated timing of an IND application as the program progresses.

◦ Advance VAX-PG through IND-enabling activities, clinical development and regulatory approval.

Our initial goal is to develop a therapeutic vaccine to slow or stop disease progression;

however, the results from clinical trials may inform the potential adoption of prophylactic immunization.

We believe we have generally demonstrated preclinical proof of concept for a periodontitis protein vaccine, the data for which was published in February 2019.

We nominated a final vaccine candidate for VAX-PG in 2022 and are conducting large-animal confirmatory studies prior to advancing the program to potential IND-enabling activities.

◦ Advance VAX-GI program research and development.

We plan to initiate a Phase 1 adult clinical study in 2026, with the primary objective of assessing safety and tolerability.

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 NIH.

We are in the process of identifying additional antigens to include with IpaB and engaged in early-stage process development activities.

◦ Leverage our platform for other discovery stage programs.

3 unchanged sentences

We have rights to a robust portfolio of patents and patent applications related to the XpressCF platform through our exclusive license from Sutro Biopharma.

We currently have five issued U.S.

patents, one issued European patent, and multiple issued patents internationally, and multiple pending patent applications in the United States and internationally that cover our vaccine candidates including vaccine formulations, protein-antigen conjugates, methods of making

conjugate vaccines with various protein-antigen conjugates and other processes related to vaccine production, enhancements of immunogenicity and methods of use.

We currently have four issued U.S.

patents, two issued European patents and multiple issued patents internationally, and multiple pending patent applications in the United States and internationally that cover our vaccine candidates including vaccine formulations, protein-antigen conjugates, methods of making conjugate vaccines with various protein-antigen conjugates and other processes related to vaccine production, enhancements of immunogenicity and methods of use.

We have utilized our cell-free protein synthesis platform to generate a pipeline of vaccine candidates that we believe, if approved, may offer important advantages over existing vaccines or for which there are no vaccines available today.

The following table summarizes our current pipeline:

Global Vaccine Market (Excluding COVID-19 Vaccines)

The global vaccine market, excluding COVID-19 vaccines, is projected to reach $80.3 billion by 2029 from $53.0 billion in 2024, a compounded annual growth rate of 8.7%.

The World Health Organization (“WHO”) has reported that non-COVID vaccine revenues have grown at nearly twice the rate of therapeutic products over the last two decades.

Conjugate vaccines, including PCVs, have historically represented the largest segment – approximately a third – of the global non-COVID vaccine market.

Global Vaccine Market

The global vaccine market size is projected to reach $115.77 billion by 2033 from an estimated $72.75 billion in 2025, growing at a compounded annual growth rate of 5.78% from 2026 to 2033.

The Prevnar franchise from Pfizer Inc.

(“Pfizer”) comprised of Prevnar 13 (“PCV13”) and PCV20, was among the highest selling non-COVID vaccine products in the world in 2024, accounting for approximately 12% of global non-COVID vaccine sales.

The pediatric vaccine market is large and well-established in the United States and European Union and growing in emerging countries.

(“Pfizer”), comprised of Prevnar 13 (“PCV13”) and PCV20, was among the highest selling vaccine products in the world in 2025, accounting for an estimated 9% of global vaccine sales.

The pediatric vaccine market is large and well-established in the United States, European Union and many other countries around the world.

The annual new birth cohort, which in North America and Europe approached approximately 10 million in 2024, drives ongoing sales year after year due to the recommended immunization schedules.

In the United States, once a new vaccine is approved by the FDA, the ACIP considers whether to recommend the use of the vaccine.

New pediatric vaccine classes that receive a recommendation from ACIP are nearly universally adopted by pediatricians and parents and are required by many schools, contributing to a national immunization rate for the diseases targeted by such vaccines of approximately 90%.

It is estimated that vaccination in children born between 1994 and 2023 in the United States will result in direct savings of $540 billion and societal savings of $2.7 trillion, making them one of the most cost-effective public health interventions.

New pediatric vaccine classes that receive a recommendation from ACIP and/or government health and professional medical organizations are widely adopted by pediatricians and parents and are required by many schools, contributing to a national immunization rate for the diseases targeted by such vaccines of approximately 90%.

It is estimated that vaccination in children born between 1994 and 2023 in the United States will result in net savings of $540 billion in direct costs and $2.7 trillion in societal costs, making them one of the most cost-effective public health interventions.

In addition, the adult vaccine market is undergoing rapid growth.

Vaccination rates among adults have historically been lower and vary by disease, though strong initiatives are underway to increase awareness and utilization.

Excluding the impact of the COVID-19 pandemic, studies estimate that 40,000 to 80,000 adults in the United States die annually of vaccine-preventable diseases, and hundreds of thousands more are hospitalized.

Vaccination rates among adults have historically been lower relative to infants and vary by disease, though strong initiatives are underway to increase awareness and utilization.

Excluding the impact of the COVID-19 pandemic, studies estimate that tens of thousands of adults in the United States die annually of vaccine-preventable diseases, and hundreds of thousands more are hospitalized.

Vaccine-preventable diseases among adults cost the U.S.

economy an estimated $27 billion annually in direct and indirect expenses.

In recent years, manufacturers have started developing more vaccines for the adult market, including Pfizer’s PCV13 and PCV20, Merck & Co., Inc.'s (“Merck”) PCV15 and Capvaxive TM (“PCV21”) and GSK plc's (“GSK”) Shingrix.

adult pneumococcal market generated estimated annual sales of approximately $1 billion to $2 billion in 2024, and Shingrix, a vaccine for shingles (herpes zoster), debuted with over $1 billion in sales in 2018 as it replaced Merck’s incumbent vaccine, Zostavax, after

receiving an ACIP preferred recommendation, and generated over $4.1 billion in global sales in 2024, in part due to increased coverage among eligible U.S.

The vaccines to prevent respiratory syncytial virus from Pfizer and GSK that were approved by the FDA in May 2023, and from Moderna that was approved by the FDA in May 2024, have generated nearly $4 billion in global sales as of December 31, 2024.

In October 2024, the ACIP voted to recommend expanding the age-based pneumococcal vaccination guidelines for pneumococcal vaccination in adults to begin at 50 years of age and older from the prior recommendation beginning at 65 years of age and older, which expands the market by adding approximately 63 million additional eligible Americans for the universal recommendation.

The complex development and production processes of vaccines create a high barrier to entry and long product lifecycles.

In recent history, four multinational companies – GSK, Merck, Pfizer and Sanofi – have been responsible for developing and introducing most new vaccines to the world.

As a result of the COVID-19 pandemic, there have been a number of new entrants into the vaccines market, including multinational companies and emerging biopharmaceutical companies.

In recent years, manufacturers have started developing more vaccines for the adult market, including Pfizer’s PCV13 and PCV20, Merck & Co., Inc.'s (“Merck”) PCV15 and PCV21, GSK plc's (“GSK”) Shingrix and multiple vaccines to prevent respiratory syncytial virus ("RSV").

adult pneumococcal market generated estimated annual sales of more than $1.5 billion in 2025, and Shingrix, a vaccine for shingles (herpes zoster), debuted with over $1 billion in sales in 2018 as it replaced Merck’s incumbent vaccine, Zostavax, after receiving an ACIP preferred recommendation, and generated over $4.8 billion in global sales in 2025.

The vaccines to prevent RSV from Pfizer and GSK that were approved by the FDA in May 2023, and from Moderna that was approved by the FDA in May 2024, generated approximately $1.8 billion in global sales in 2025.

In October 2024, the ACIP voted to recommend expanding the age-based pneumococcal vaccination guidelines for pneumococcal vaccination in adults to begin at 50 years of age and older from the prior recommendation beginning at 65 years of age and older, which expanded the market by adding approximately 62 million additional eligible Americans for the universal recommendation.

Pneumococcal Disease

1 unchanged sentence

It can result in IPD, including meningitis and bacteremia, and non-invasive pneumococcal disease, including pneumonia, otitis media and sinusitis.

The global incidence of pneumococcal disease is driven by emerging serotypes not covered by currently available vaccines.

In the United States, pneumococcal pneumonia is estimated to result in approximately 150,000 hospitalizations each year.

Streptococcus pneumoniae is among the WHO’s top antibiotic-resistant pathogens to be urgently addressed, and the United States CDC lists drug-resistant Streptococcus pneumoniae as a “serious threat.” In children under five, Streptococcus pneumoniae is a leading cause of vaccine-preventable deaths globally.

Although not considered invasive disease, it is estimated that acute otitis media affects over 5 million children and results in greater than 10 million antibiotic prescriptions annually in the United States.

Global pneumococcal disease in children is driven by emerging serotypes not covered by currently available vaccines and in adults by not only emerging serotypes, but also fragmented coverage of today's standard-of-care vaccines.

In the United States, pneumococcal pneumonia is estimated to result in approximately 225,000 U.S.

adult hospitalizations each year.

Streptococcus pneumoniae is among the WHO’s top antibiotic-resistant pathogens to be urgently addressed, and the United States CDC lists drug-resistant Streptococcus pneumoniae as a “serious threat.” In children under five, Streptococcus pneumoniae is the leading cause of vaccine-preventable deaths globally, resulting in approximately 300,000 deaths annually.

It is estimated that acute otitis media affects approximately 5 million children and results in greater than 10 million antibiotic prescriptions annually in the United States.

Pneumococci also cause over 50% of all cases of bacterial meningitis in the United States.

12 unchanged sentences

After the ACIP recommendation of PCV20 in late 2021 eliminated the need for PPSV23 in a large part of the covered population, PPSV23 has declined from more than 50% of the U.S.

adult market share to now approximately 3%.

adult market share to less than 3%.

Polysaccharide vaccines induce a B-cell response only and do not induce a T-cell dependent immune response.

28 unchanged sentences

Based on its broader coverage of then-emerging strains, PCV13 was adopted as the standard-of-care in the United States and Europe.

Synflorix continues to be used primarily in emerging countries.

Synflorix's use has been limited primarily to emerging countries.

PCV13 contains the seven serotypes originally included in Prevnar plus six more serotypes of Streptococcus pneumoniae (1, 3, 5, 6A, 7F and 19A) and was approved and launched in the United States in 2010.

44 unchanged sentences

However there has been a phenomenon called serotype replacement, whereby a void is created when serotypes are taken out of circulation after widespread vaccination.

As a result, there has been an increase in incidence caused by serotypes not covered by PCV13 that now cause most residual pneumococcal disease.

As a result, serotypes not covered by PCV13 now cause residual pneumococcal disease.

Broader-spectrum PCVs were historically required to maintain protection against historically pathogenic strains while expanding coverage to address current circulating and emerging strains.

This serotype replacement has led to the development of a third generation of conventional PCVs, inclusive of PCV15 and PCV20.

Despite these developments, the coverage of these third-generation vaccines addresses only half of the disease in circulation.

Although PCV21 was approved despite lacking protection against certain historically pathogenic strains, it is only approved in the adult population and did not receive a preferred

recommendation despite its disease coverage, and is recommended solely as an alternative to PCV20 alone or PCV15 and PPSV23.

Although PCV21 was approved despite lacking protection against certain historically pathogenic strains, it is only approved in the adult population and did not receive a preferred recommendation despite its disease coverage, and is recommended solely as an alternative to PCV20 alone or PCV15 and PPSV23.

VAX-31, if approved, would increase coverage to more than 95% of IPD currently circulating in the U.S.

adult population aged 50 and over.

In infants, VAX-31 would increase coverage to approximately 94% of IPD and 93% of otitis media currently circulating in the U.S.

infant population under the age of five.

In the pediatric population, VAX-31 is 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.

Pneumococcal disease surveillance has been conducted by the CDC in the United States and by the UK Health Security Agency.

20 unchanged sentences

When PCV20 was compared to PCV13 in a well-controlled Phase 3 study in infants, the IgG antibody responses directed against the polysaccharides of interest for all thirteen of the common strains in each vaccine were lower for PCV20 (Figure 5).

In 2020, Pfizer presented results of a well-controlled Phase 3 study in

adults, aged 60 and over, where they compared PCV20 to PCV13.

In 2020, Pfizer presented results of a well-controlled Phase 3 study in adults, aged 60 and over, where they compared PCV20 to PCV13.

In that study, the OPA responses directed against the polysaccharides of interest for all thirteen of the common strains were lower for PCV20 (Figure 6).

1 IgG Geometric Mean Concentrations post-dose 4 – Prevnar 20 BLA Clinical Review Memorandum by FDA (STN:

1 IgG Geometric Mean Concentrations post-dose 4 – Prevnar 20 Biologics License Application ("BLA") Clinical Review Memorandum by FDA (STN:

April 27, 2023.

14 unchanged sentences

Synthesizing proteins outside of a living host cell provides us greater freedom to design and produce specific proteins of interest under optimized conditions.

We separate the precise cellular machinery required for transcription, translation and

energy production—the critical components for protein production—into an Escherichia coli (" E.

We separate the precise cellular machinery required for transcription, translation and energy production—the critical components for protein production—into an Escherichia coli (" E.

coli " ) -derived extract.

15 unchanged sentences

To harness this potential potency advantage, we have elected to construct conjugates with a lower ratio of protein carrier to polysaccharide than conventional PCVs.

Our VAX-24 adult Phase 2 clinical studies validated our carrier-sparing approach to develop broader-spectrum PCVs.

As a result, we believe we can incorporate more monovalent conjugates to create an even more broad-spectrum vaccine with less protein carrier per conjugate in order to minimize carrier suppression.

Our clinical studies to date validated our carrier-sparing approach to develop broader-spectrum PCVs.

As a result, we believe we can incorporate more monovalent conjugates to

create an even more broad-spectrum vaccine with less protein carrier per conjugate in order to minimize carrier suppression.

Better Chemistry

3 unchanged sentences

Our PCV Franchise

We are developing broad-spectrum investigational PCVs designed to minimize carrier suppression.

We currently have two PCV candidates in our differentiated PCV franchise:

VAX-31, a 31-valent, broad-spectrum, carrier-sparing investigational PCV, which we are developing for both the infant and adult populations, and VAX-24, a 24-valent, broad-spectrum, carrier-sparing investigational PCV which we are developing for the infant population.

VAX-31, the broadest-spectrum PCV in the clinic, is designed to provide protection against both currently circulating and historically prevalent serotypes and cover more than 95% and 94% of IPD circulating in the U.S.

We are developing broad-spectrum investigational PCVs designed to improve serotype coverage compared to current standard-of-care PCVs and minimize carrier suppression.

We currently have three PCV candidates in our differentiated PCV franchise:

VAX-31, a 31-valent, broad-spectrum, carrier-sparing investigational PCV, which we are developing for both the infant and adult populations, VAX-24, a 24-valent, broad-spectrum, carrier-sparing investigational PCV for which we have completed a Phase 2 trial in both the adult and infant populations, and VAX-XL, a third-generation PCV candidate designed to provide the broadest coverage of any PCV currently in development.

VAX-31, the broadest-spectrum PCV in the clinic, is designed to provide protection against both currently circulating and historically prevalent serotypes and cover approximately 95% and 92% of IPD circulating in the U.S.

adult (ages 50 and older) and infant (under the age of five) populations, respectively.

4 unchanged sentences

The click chemistry we use for site-specific conjugation may also minimize damage to the critical immunogenic epitopes on the protein carrier and the polysaccharides through milder and shorter reactions, while other PCVs use conventional chemistries that involve harsher and longer reaction conditions.

Furthermore, VAX-31 and VAX-24 improve upon the serotype spectrum of coverage relative to PCV15 and PCV20 in both the adult and infant populations and use less protein carrier per conjugate than these conventional chemistry PCVs.

Furthermore, VAX-31 and VAX-24 improve upon the serotype spectrum of coverage relative to PCV15 and PCV20 in both the adult and infant populations, and VAX-31 improves on the same in the adult population relative to PVC21, and use less protein carrier per conjugate than these conventional chemistry PCVs.

In aggregate, VAX-31 contains more protein carrier, and VAX-24 contains a similar amount of protein carrier, relative to PCV15 and PCV20.

We believe the resulting decreased carrier burden per conjugate of VAX-31 and VAX-24 are critical for minimizing carrier suppression and producing broader-spectrum pneumococcal vaccines without sacrificing immunogenicity.

Where appropriate, we capitalize on the efficiencies of well-established clinical, manufacturing and regulatory precedents by leveraging conventional methods for the development of VAX-31 and VAX-24.

For example, our polysaccharide

antigens are primarily made using conventional fermentation and purification techniques and activated through conventional methods.

Where appropriate, we capitalize on the efficiencies of well-established clinical, manufacturing and regulatory precedents by leveraging conventional methods for the development of our PCV candidates.

For example, our polysaccharide antigens are primarily made using conventional fermentation and purification techniques and activated through conventional methods.

They are also labeled through conventional amination methods prior to being conjugated to eCRM.

In addition, we use the same critical quality attribute assays for molecular weight and free polysaccharide that have served as the physicochemical measures of conjugates and also serve as predictors of their immunogenicity in vivo.

In addition, we use the same critical quality attribute assays for molecular weight and free polysaccharide that have served as the

physicochemical measures of conjugates and also serve as predictors of their immunogenicity in vivo.

We also use conventional IgG and OPA serological assays to gauge the immunogenicity of our conjugates, which have served as surrogate immunological endpoints in clinical studies that enabled the approval of PCV13, PCV15, PCV20 and PCV21.

We are pursuing a well-characterized clinical development path for VAX-31 and VAX-24, consistent with other PCV developers.

We are pursuing a well-characterized clinical development path for our PCV candidates, consistent with other PCV developers.

We have been able to conduct smaller and shorter clinical trials that target immune endpoints (e.g., OPA and IgG responses) previously recognized by regulatory authorities, and anticipate that we will be able to conduct such studies going forward.

3 unchanged sentences

Clinical Development Overview

We are pursuing clinical development for adults with VAX-31 and for the pediatric population currently with VAX-24 and VAX-31.

We are pursuing clinical development for adults with VAX-31 and, for the pediatric population, have completed a Phase 2 study with VAX-24 and are currently conducting a Phase 2 study with VAX-31.

Adult Indication

We have selected VAX-31 to exclusively advance to an adult Phase 3 program.

We have selected VAX-31 to advance to an adult Phase 3 program, which was initiated in December 2025.

For VAX-31, we achieved clinical proof of concept in September 2024 when we announced positive topline results from a Phase 1/2 study evaluating the safety, tolerability and immunogenicity of VAX-31 in healthy adults aged 50 and older.

Based on these positive results, we selected VAX-31 to advance to an adult Phase 3 program, and plan to select the dose prior to the initiation of such program.

Following an FDA End-of-Phase 2 meeting, we plan to initiate a Phase 3 pivotal, non-inferiority study by mid-2025 and announce topline safety, tolerability and immunogenicity data 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.

Based on these positive results, we selected the High Dose of VAX-31 to advance to an adult Phase 3 program.

Following an FDA End-of-Phase 2 meeting, we initiated a Phase 3 pivotal, non-inferiority study in December 2025 and expect to announce topline safety, tolerability and immunogenicity data in the fourth quarter of 2026.

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 lower-valency pneumococcal vaccines (“OPUS-3”).

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).

Subject to the results of the adult Phase 3 studies, we would expect to submit a BLA shortly following the completion of the last Phase 3 study.

For adults, the FDA has granted VAX-31 a BTD, which is designed to expedite the development and review of drugs that are intended to treat serious or life-threatening conditions.

A BTD is based upon preliminary clinical evidence indicating that the drug or vaccine may demonstrate substantial improvement over available therapies on one or more clinically significant endpoints.

For adults, the FDA has granted VAX-31 BTD for the prevention of IPD as well as pneumonia caused by Streptococcus pneumoniae .

A BTD is designed to expedite the development and review of drugs that are intended to treat serious or life-threatening conditions and is based upon preliminary clinical evidence indicating that the drug or vaccine may demonstrate substantial improvement over available therapies on one or more clinically significant endpoints.

Infant Indication

We are currently conducting Phase 2 infant studies for both VAX-24 and VAX-31.

In March 2023, we announced that the first participants were dosed in the first stage of a Phase 2 study of VAX-24 in healthy infants and, in July 2023, we announced that the ongoing study had advanced to the second and final stage.

The independent DSMB approved advancing to the second stage of the study following the review of the safety and tolerability results from the first stage.

In March 2024, we announced the completion of enrollment in the Phase 2 clinical study.

We expect to announce topline safety, tolerability and immunogenicity data from the VAX-24 Phase 2 primary three-dose immunization series, which is fully enrolled with 802 healthy infants, by the end of the first quarter of 2025, followed by topline data from the booster dose by the end of 2025.

For VAX-31, in November 2024, we announced the FDA cleared the IND application for the prevention of IPD in infants.

In December 2024, we announced that the first participants were dosed in the first stage of a Phase 2 study of VAX-31 in healthy infants, and in February 2025, we announced that the ongoing study had advanced to the second and final stage of the study and that the first participants had been dosed.

We expect to announce topline safety, tolerability and

immunogenicity data from the VAX-31 Phase 2 primary three-dose immunization series in mid-2026, followed by topline data from the booster dose approximately nine months later.

We have completed a Phase 2 study with VAX-24 and and are currently conducting a Phase 2 study with VAX-31 for the prevention of IPD in infants.

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.

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.

In this study, VAX-24 was well-tolerated and demonstrated a safety profile similar to PCV20 across all doses studied.

The results from this study informed advancement of our modified VAX-31 infant Phase 2 dose-finding study.

The final positive data from the VAX-24 infant Phase 2 dose-finding study further validated our rationale for exploring higher doses in the ongoing VAX-31 infant Phase 2 study.

For VAX-31, 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 healthy infants, and in February 2025, we announced that the ongoing study

had advanced to the second stage of the study and that the first participants had been dosed.

In September 2025, we announced advancement of the modified VAX-31 infant Phase 2 randomized, dose-finding study to the third and final stage.

The study advanced to the third and final stage following modifications to the protocol to add a new dose arm to evaluate the VAX-31 Optimized Dose (majority of serotypes dosed at 4.4mcg and the balance dosed at 3.3mcg) and discontinue enrollment in the Low Dose arm.

The Middle and High Dose arms are continuing as planned.

In January 2026, we announced that we had completed enrollment of this study.

Clinical Data:

24 unchanged sentences

As shown in Figure 13, based on the full six-month safety data, VAX-31 was observed to be well tolerated and demonstrated a safety profile at all doses studied through the full six-month evaluation period similar to PCV20.

As shown in Figure 14 and Figure 15, frequently reported local and systemic reactions were generally mild-to-

moderate, resolving within several days of vaccination, with no meaningful differences observed across the cohorts.

As shown in Figure 14 and Figure 15, frequently reported local and systemic reactions were generally mild-to-moderate, resolving within several days of vaccination, with no meaningful differences observed across the cohorts.

No serious adverse events were considered to be related to study vaccines.

5 unchanged sentences

At the Middle Dose, 13 of 20 serotypes had a GMR greater than 1.0 and five serotypes achieved statistically higher immune responses com pared to PCV20.

At the low dose, 18 of 20 serotypes met the

OPA response non-inferiority criteria, 8 of 20 serotypes had a GMR greater than 1.0 and three serotypes achieved statistically higher immune responses.

At the Low Dose, 18 of 20 serotypes met the OPA response non-inferiority criteria, 8 of 20 serotypes had a GMR greater than 1.0 and three serotypes achieved statistically higher immune responses.

As shown in Figure 17, for all 11 incremental serotypes unique to VAX-31, and not in PCV20, all three doses met the superiority criter ia (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).

Based on these positive results, we selected VAX-31 to advance to an adult Phase 3 program, and plan to select the dose prior to the initiation of such program.

Following an FDA End-of-Phase 2 meeting, we plan to initiate a Phase 3 pivotal, non-inferiority study by mid-2025 and announce topline safety, tolerability and immunogenicity data 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.

Based on these positive results, we selected the High Dose of VAX-31 to advance to an adult Phase 3 program.

Following an FDA End-of-Phase 2 meeting, we are advancing a comprehensive Phase 3 adult clinical program for VAX-31 to support a planned BLA submission.

The announced Phase 3 clinical studies, which were finalized in consultation and alignment with the FDA, include the pivotal, noninferiority trial evaluating VAX-31 for the prevention of IPD and pneumonia in adults (OPUS-1);

a trial evaluating VAX-31 when administered concomitantly with a licensed, high-dose seasonal influenza vaccine in pneumococcal-naïve adults (OPUS-2);

and a trial in adults who have previously received a pneumococcal vaccine (OPUS-3), all of which are currently enrolling participants.

Across these three studies, approximately 6,000 adults are expected to be enrolled in total, of whom approximately 3,400 will receive VAX-31, with the intent to generate a broad and robust safety, tolerability and immunogenicity dataset.

We are also planning for a manufacturing consistency study (e.g., a lot-to-lot study).

OPUS-1 is evaluating the safety, tolerability and immune responses of VAX-31 in approximately 3,560 adults aged 50 and older through direct, head-to-head comparisons with both PCV21 and PCV20, the current standard-of-care PCVs, with the objective of establishing a best-in-class profile for VAX-31.

The trial is also evaluating the safety, tolerability and immune responses of VAX-31 in approximately 440 adults aged 18-49.

OPUS-1 is being conducted at approximately 50 sites in the United States.

The key primary immunogenicity objectives of this trial are to demonstrate (i) noninferiority if the lower bound of the two-sided 95% confidence interval for the OPA GMR of VAX-31 exceeds 0.667 compared with PCV21 and/or PCV20 for the 28 serotypes shared with one or both comparators and (ii) superiority if the lower bound of the two-sided 95% confidence interval of the OPA GMR exceeds 2.0 for the three serotypes unique to VAX-31 and serotype 20B versus the comparator vaccines.

The trial is also evaluating the safety, tolerability and immune responses of VAX-31 in adults aged 18-49.

Key secondary immunogenicity objectives are included to evaluate VAX-31 based on additional measures of non-inferiority, superiority and statistically greater immune responses.

OPUS-2 is a randomized, double-blind, placebo-controlled clinical trial designed to evaluate the safety, tolerability and immunogenicity of VAX-31 when administered either concomitantly with or one month following administration of a licensed, high-dose seasonal influenza vaccine in pneumococcal-naïve, healthy U.S.

adults aged 50 years and older.

The study is expected to enroll approximately 1,300 participants at approximately 25 sites in the United States.

The results of this descriptive study are intended to inform the design of a potential post-licensure outcomes study that further evaluates VAX-31 in concomitant use with an influenza vaccine and to provide supportive evidence as part of the broader Phase 3 dataset.

OPUS-3 is a randomized, double-blind, active-controlled, descriptive clinical trial designed to evaluate the safety, tolerability and immunogenicity of a single dose of VAX-31 in approximately 720 healthy U.S.

adults aged 50 years and

older with a history of prior pneumococcal vaccination at least six months prior.

The study will be conducted at approximately 30 sites in the United States.

Contextual Information:

3 unchanged sentences

The Phase 1 portion of the study evaluated the safety and tolerability of a single injection of VAX-24 at three dose levels, 1.1mcg, 2.2mcg and 2.2mcg/4.4mcg, and compared to PCV20 in 64 healthy adults aged 18 to 49.

Participants were

randomized equally in four separate arms and were evaluated for safety 8 and 29 days after dosing.

Participants were randomized equally in four separate arms and were evaluated for safety 8 and 29 days after dosing.

The Phase 2 portion evaluated the safety, tolerability and immunogenicity of a single injection of VAX-24 at the same three dose levels and compared to a single injection of PCV20 in 771 healthy adults 50 to 64 years of age.

13 unchanged sentences

Regulatory Threshold for Superiority (LL95%CI > 10%)

Based on the results of this study, the FDA granted a BTD for VAX-24 in adults.

Based on the results of this study, the FDA granted a BTD for VAX-24 for the prevention of IPD in adults.

Phase 2 Clinical Study in Adults 65 and Older

8 unchanged sentences

In this Phase 2 study, VAX-24 demonstrated robust OPA immune responses across all 24 serotypes at all doses studied (1.1mcg, 2.2mcg, and 2.2mcg/4.4mcg), confirming the prior Phase 2 adult study results.

The VAX-24 2.2mcg dose, which we had planned to advance to a potential Phase 3 program prior to our decision to advance exclusively VAX-31, showed an overall improvement in immune responses compared to PCV20 relative to the results from the prior Phase 2 study in adults aged 50-64.

The six-month safety data from both adult studies showed safety and tolerability results for VAX-24 similar to PCV20 at all doses studied.

37 unchanged sentences

Infant Indication

We expect the clinical development of VAX-24 and VAX-31 in infants to follow the same approach utilized for PCV13, PCV15 and PCV20, where vaccine effectiveness against IPD was inferred from immunologic correlates.

VAX-24 and VAX-31 approvals in the pediatric population are expected to be based on non-inferiority comparisons of IgG responses, whereas in the adult population approvals have been based on non-inferiority comparisons of OPA responses.

with the approval processes for PCV13, PCV15 and PCV20 in infants, we do not anticipate that clinical field efficacy trials will be required for VAX-24 or VAX-31 in the pediatric population.

Our Phase 3 and commercial strategy for VAX-24 and/or VAX-31 for the infant indication will depend on several factors, including the results from and timing of our ongoing Phase 2 studies for each program.

If our Phase 2 trials are completed successfully, we expect our Phase 3 program(s) in the pediatric population to focus on evaluating non-inferiority to PCV20 for immunogenicity and seroconversion or antibody concentration threshold;

We expect the clinical development of VAX-24 and VAX-31 in infants to follow similar approaches utilized for PCV13, PCV15 and PCV20, where vaccine effectiveness against IPD was inferred from immunologic correlates, and approvals are based on non-inferiority comparisons of IgG responses and totality of data, whereas in the adult population approvals have been based on non-inferiority comparisons of OPA responses.

Consistent with the approval processes for PCV13, PCV15 and PCV20 in infants, we do not anticipate that clinical field efficacy trials will be required for VAX-24 or VAX-31 in the pediatric population.

Our Phase 3 and commercial strategy for VAX-24 or VAX-31 for the infant indication will depend on several factors, including the results from our ongoing Phase 2 study for VAX-31.

Pending the outcome of our Phase 2 VAX-31 study, we plan to initiate a Phase 3 program with an Optimized Dose formulation of VAX-24 or VAX-31.

We expect our Phase 3 program in the pediatric population to focus on evaluating non-inferiority to PCV20, the current standard of care in infants, for immunogenicity and seroconversion or antibody concentration threshold;

assessing U.S.

3 unchanged sentences

This approach is similar to the approach utilized to develop PCV13, where the immunogenicity of PCV13 was compared to the original 7-valent Prevnar product, which was the standard of care at the time, as well as the approaches for PCV15 and PCV20, which were compared to PCV13.

The VAX-24 Phase 2 infant study is a randomized, observer-blind, dose-finding two-stage clinical study evaluating the safety, tolerability and immunogenicity of VAX-24 at three dose levels, 1.1mcg, 2.2mcg, and 2.2mcg/ 4.4mcg, and compared to PCV15 and PCV20 in healthy infants.

The VAX-24 Phase 2 infant study was a randomized, observer-blind, dose-finding two-stage clinical study evaluating the safety, tolerability and immunogenicity of VAX-24 at three dose levels, 1.1mcg, 2.2mcg, and 2.2mcg/ 4.4mcg, and compared to PCV15 and PCV20 in healthy infants.

The Stage 1 portion of the study evaluated the safety and tolerability of a single injection of VAX-24 at three dose levels compared to PCV15 in 48 infants in a dose-escalation approach.

The Stage 2 portion is evaluating the safety, tolerability and immunogenicity of VAX-24 at three dose levels and compared to PCV20 in 754 healthy infants.

The key prespecified immunogenicity study endpoints include an assessment of immune responses for all three VAX-24 doses and compared to PCV20 on the shared serotypes measured at 30 days post-dose three (“PD3”) and post-dose four (“PD4”).

Immune responses will be assessed based on anti-pneumococcal polysaccharide serotype-specific IgG responses (proportion of participants achieving the accepted IgG threshold value of ≥0.35mcg/ml) at 30 days PD3 and IgG geometric mean titer ratios at 30 days PD4.

All participants in the study will be evaluated for safety through six months following the booster dose.

The Stage 2 portion evaluated the safety, tolerability and immunogenicity of VAX-24 at three dose levels and compared to PCV20 in 789 healthy infants.

In line with recommendations from the ACIP, the study design included 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.

The key prespecified immunogenicity study endpoints included an assessment of immune responses for all three VAX-24 doses and compared to PCV20 on the shared serotypes measured at 30 days post-dose three (“PD3”) and post-dose four (“PD4”).

Immune responses were assessed based on anti-pneumococcal polysaccharide serotype-specific IgG responses (proportion of participants achieving the accepted IgG threshold value of ≥0.35mcg/ml) at 30 days PD3 and IgG geometric mean titer ratios at 30 days PD4.

All participants in the study were evaluated for safety through six months following the booster dose.

Figure 28 is a schematic of the overall study design of our VAX-24 infant Phase 2 study:

We expect to announce topline safety, tolerability and immunogenicity data from the primary three-dose immunization series of the Phase 2 study, which is fully enrolled with 802 healthy infants, by the end of the first quarter 2025, followed by topline data from the booster dose by the end of 2025.

The VAX-31 Phase 2 infant study is a randomized, double-blind, active controlled, dose-finding, two-stage clinical study evaluating the safety, tolerability and immunogenicity of VAX-31 compared to PCV20 in healthy infants.

In March 2025, we announced positive topline, interim data from the VAX-24 infant Phase 2 study and, in November 2025, we announced final safety, tolerability, and immunogenicity results 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.

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.

Post-dose 3, all VAX-24 doses met target precedent Phase 2 non-inferiority (NI) 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) 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 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.

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.

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.

In this study, VAX-24 was well-tolerated and demonstrated a safety profile similar to PCV20 across all doses studied.

Frequently reported local and systemic reactions were generally mild-to-moderate, resolving within several days of vaccination, with no meaningful differences observed across the cohorts.

No serious adverse events were considered to be related to study vaccines.

The final positive data from the VAX-24 infant Phase 2 dose-finding study further validated our rationale for exploring higher doses in the ongoing VAX-31 infant Phase 2 study.

The VAX-31 Phase 2 infant study is a randomized, double-blind, active controlled, dose-finding, three-stage clinical study evaluating the safety, tolerability and immunogenicity of VAX-31 compared to PCV20 in healthy 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.

Stage 2 of the study is evaluating the safety, tolerability and immunogenicity of VAX-31 at the same three dose levels and compared to PCV20 in approximately 750 healthy infants.

In line with recommendations from the ACIP, and consistent with our approach for the VAX-24 infant program, 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.

The key prespecified immunogenicity study endpoints include an assessment of immune responses for each of the VAX-31 dose levels in comparison with PCV20 for the 20 common and 11 unique serotypes in VAX-31.

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 continued the standard dosing regimen as part of Stage 2.

Stage 2 is evaluating the safety, tolerability and immunogenicity of VAX-31 at the same three dose levels and compared to PCV20.

In line with recommendations from the ACIP, the study includes a primary immunization series consisting of three doses given at two, four and six months of age, followed by a subsequent booster dose at 12-15 months of age.

On 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 the VAX-31 Optimized Dose (majority of serotypes dosed at 4.4mcg and the balance dosed at 3.3mcg) and discontinue enrollment in the Low Dose arm.

The Middle and High Dose arms are continuing as planned.The key prespecified immunogenicity study endpoints include an assessment of immune responses for each of the VAX-31 dose levels in comparison with PCV20 for the 20 common and 11 unique serotypes in VAX-31.

Post-primary series PD3 immune responses will be assessed based on serotype-specific IgG seroconversion rates (proportion of participants achieving the accepted IgG threshold value of ≥0.35mcg/mL) at 30 days PD3.

2 unchanged sentences

Figure 29 is a schematic of the overall study design of our VAX-31 infant Phase 2 study:

We expect to announce topline data from the primary three-dose immunization series of the study in mid-2026, followed by topline data from the booster dose approximately nine months later .

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.

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.

Platform Application Two:

13 unchanged sentences

In addition, Group A Strep drives significant antibiotic use, especially among children, and as such contributes towards increased antimicrobial resistance.

Among older adults (≥ 65 years) in the United States, rates of invasive disease and deaths caused by Group A Strep have more than doubled over the last decade.

Among older adults (≥ 65 years) in the United

States, rates of invasive disease and deaths caused by Group A Strep have been increasing over the last decade.

Some of the most serious consequences of Group A Strep include invasive diseases such as flesh-eating disease (necrotizing fasciitis), sepsis and sequelae such as rheumatic heart disease ("RHD").

Approximately 40 million people are currently affected by RHD worldwide.

An estimated 55 million people are affected by RHD each year worldwide.

Importantly, the majority of Group A Strep infections lead to pharyngitis, commonly known as strep throat, which is highly prevalent in school-age children.

13 unchanged sentences

Our VAX-A1 vaccine development program has been funded in part by a grant obtained from Combating Antibiotic Resistant Bacteria Biopharmaceutical Accelerator (“CARB-X”), a global non-profit partnership dedicated to accelerating antibacterial innovation to tackle the rising global threat of drug-resistant bacteria.

The CARB-X grant provided funding of up to $11.7 million upon the achievement of VAX-A1 development milestones through June 2024.

As of the second quarter of 2024, all of these milestones had been successfully achieved, and no further amounts will be funded under this CARB-X grant.

We nominated the final vaccine candidate for our VAX-A1 program and initiated IND-enabling activities in 2021.

We continue to advance the development of VAX-A1 and we intend to provide further information about the anticipated timing of an IND application as the program progresses.

Upon completion of the preclinical development program and IND-enabling activities for VAX-A1, we intend to conduct a multi-center, randomized, placebo-controlled Phase 1 study in adults.

The primary objectives of the initial clinical trial will be to evaluate safety and tolerability.

Secondary exploratory endpoints will be to measure IgG immune response to the vaccine antigens and to evaluate the ability of the antibodies produced in response to vaccination to inhibit and prevent infections caused by Group A Strep.

We nominated the final vaccine candidate for our VAX-A1 program and initiated IND-enabling activities in 2021 and plan to initiate a Phase 1 adult clinical study in 2026, with the primary objective of assessing safety and tolerability.

Platform Application Three:

1 unchanged sentence

We believe we can also develop novel protein vaccine candidates constructed using “tough-to-make” protein antigens uniquely able to be expressed using the platform.

In particular, the lack of a cellular membrane in our platform allows for the exogenous addition of components to manipulate transcription, translation and folding by modification of reaction

In particular, the lack of a cellular membrane in our platform allows for the exogenous addition of components to manipulate transcription, translation and folding by modification of reaction conditions.

Furthermore, removal of the typical restriction to maintain cell viability also creates unique avenues for optimizing and promoting protein production for antigens that might be cytotoxic to a cell-based system or require non-physiological conditions for optimal protein folding.

Thus, utilizing these advantages, we believe we can express and purify important protein targets to generate unique candidates that are beyond the scope of traditional production systems.

Our therapeutic periodontitis vaccine candidate is the first example of a “tough-to-make” protein-based vaccine.

Periodontitis Disease Background and Market Opportunity

Periodontal disease is a highly complex, chronic oral inflammatory disease that leads to the destruction of the soft and hard tissues supporting the teeth.

The subgingival niche (below the gum margin of teeth) is populated by a diverse polymicrobial plaque.

It is increasingly understood that the shift from periodontal health to disease is associated with changes in the microbial composition of the subgingival plaque, including activities of bacteria such as Porphyromonas gingivalis ("P.

gingivalis").

The development of precise approaches to control this keystone pathogen, such as a vaccine, could then positively impact the periodontal disease burden.

Those with periodontitis also have an increased risk for heart attack, stroke and other serious cardiovascular events.

In addition to gum and tooth disease, periodontal inflammation and infection with P.

gingivalis have been linked to atherosclerotic heart disease mediated by P.

gingivalis residing in atherosclerotic plaque.

While we are focused on the treatment of periodontal disease with this vaccine candidate, if P.

gingivalis is found to be causative in other chronic disorders, our vaccine candidate could potentially be a highly effective treatment and allow disease intervention at a much earlier stage of the disease.

For example, recent research has suggested the potential for a link between P.

gingivalis and Alzheimer’s disease.

Neither the natural host immune response nor currently available treatments are curative for periodontal disease.

Existing treatment includes highly aggressive and invasive procedures, including scaling and root planing and surgical intervention, coupled with antibiotic use.

Despite these types of aggressive treatments, diseased sites frequently progress, leading to tooth loss.

Thus, the development of an effective vaccine for periodontitis would be highly desirable.

Periodontitis is a highly prevalent disease impacting an estimated 40% of U.S.

adults above the age of 30, and with similar rates globally.

Periodontal disease caused an estimated loss of approximately $330 billion in the United States and Europe in 2018, with the direct costs alone exceeding $6 billion.

The indirect costs are multiples of the direct costs as a result of high rates of edentulism (loss of teeth) and increased risk of many other diseases mentioned above.

We are developing a novel protein vaccine candidate, VAX-PG, targeting P.

gingivalis that incorporates protein antigens that we believe are uniquely enabled with our technology.

Our initial goal is to develop a therapeutic vaccine to slow or stop disease progression;

however, the results from clinical trials may inform the potential adoption of prophylactic immunization.

VAX-PG, which includes cell-free produced P.

gingivalis virulence factors, including gingipains, were tested in a preclinical model that mimics periodontal disease.

The results, which we believe generally demonstrate preclinical proof of concept for a periodontitis protein vaccine, were published in the Journal of Clinical Periodontology in February 2019.

The vaccine elicited protein-specific IgG response following immunization and protected mice from P.

gingivalis-elicited oral bone loss.

Shown in Figure 31 is the objective bone loss of VAX-PG with alum, Monophospholipid A, or no adjuvant.

Immunization with all formulations of VAX-PG provided significant protection against oral bone loss compared to the no vaccine oral challenged control group (p<0.01, ANOVA with Dunns multiple comparisons).

ABC = alveolar bone crest

CEJ = cement-enamel junction

Shown below in Figure 32 are pictures of representative mouse jaws from the experiment.

As can be seen, the vaccinated mice had considerably less bone loss than the unvaccinated and challenged control animals.

We nominated a final vaccine candidate for our VAX-PG program in 2022 and are conducting large-animal confirmatory studies prior to advancing the program to potential IND-enabling activities.

Upon completion of the preclinical development program and IND-enabling activities for VAX-PG, if successful, we intend to conduct a multi-center, randomized, placebo-controlled Phase 1/2 study in adults with mild to moderate chronic periodontal disease.

The primary objectives of the initial clinical trial will be to evaluate safety and tolerability.

VAX-GI is a novel preclinical vaccine candidate being developed as a preventative treatment for dysentery and shigellosis, which is caused by Shigella bacteria.

34 unchanged sentences

Unvaccinated control mice had very low to no survival.

We plan to pursue conjugate and protein-only approaches simultaneously, as shown in Figure 34, and we are currently optimizing process for scale-up and production.

Our VAX-GI vaccine development program is currently funded in part by two grants obtained from the NIH administered by the University of Maryland, Baltimore.

Our first grant from the NIH was awarded in April 2021 and provides for potential funding up to five years totaling approximately $0.5 million.

In June 2023, we received another grant from the NIH that provides for potential funding up to five years totaling approximately $4.6 million.

We have received and expect to continue to receive funding under each of these grants.

We plan to pursue conjugate and protein-only approaches simultaneously, as shown in Figure 34.

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 NIH.

Manufacturing and Supply

28 unchanged sentences

We currently do not own or operate any manufacturing facilities, but our strategic partnerships with Lonza and other contract manufacturing organizations (“CMOs”) provide us with access to substantial resources to facilitate an independent supply path to the market.

We have entered into agreements with Lonza, a leading global contract manufacturer with deep domain expertise and experience in large and small-scale production of clinical, as well as commercial-stage products, to secure capacity, technical expertise and resources to support the production of eCRM, polysaccharides and drug substance for our VAX-31 and VAX-24 Phase 3 programs.

We have also entered into a new commercial manufacturing agreement

with Lonza to support the potential global commercialization of VAX-31 and VAX-24 in both the adult and pediatric populations.

We have also entered into a commercial manufacturing agreement with Lonza to support the potential global commercialization of our PCV candidates in both the adult and pediatric populations.

This agreement complements our plans to utilize existing Lonza infrastructure to advance clinical development and the anticipated initial U.S.

launch of VAX-31 for the adult population.

We have relationships with other leading CMOs for the production of the final drug product for VAX-31 and VAX-24, for the extract and lysates that we use to manufacture eCRM and for certain raw materials.

We have relationships with other leading CMOs for the production of the final drug product for our PCV candidates, for the extract and lysates that we use to manufacture eCRM and for certain raw materials.

We have an agreement with Sutro Biopharma pursuant to which Sutro Biopharma supplies us with extract and custom reagents for use in manufacturing preclinical and certain clinical supply of vaccine compositions.

In December 2019, we exercised our right to require Sutro Biopharma to establish a second supplier for extract and custom reagents to support future clinical and commercial needs and thereafter initiated a tech transfer to a CMO as a second supplier of extract.

2019, we exercised our right to require Sutro Biopharma to establish a second supplier for extract and custom reagents to support future clinical and commercial needs and thereafter initiated a tech transfer to a CMO as a second supplier of extract.

In December 2022, we entered into a separate agreement with Sutro Biopharma pursuant to which we enhanced our rights with the second supplier of extract and acquired an option to access expanded rights to develop and manufacture extract, among other rights.

In November 2023, we exercised this option and entered in a manufacturing rights agreement to obtain control over manufacturing and development of cell-free extract for our vaccine candidates.

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.

Lonza Agreements

9 unchanged sentences

In February 2023, we entered into another non-exclusive development and manufacturing services agreement with Lonza effective as of March 1, 2023 (the “2023 Lonza DMSA”).

Pursuant to the 2023 Lonza DMSA, Lonza will perform manufacturing process development and the manufacture of components for VAX-24 and VAX-31, including the polysaccharide antigens, our proprietary eCRM protein carrier and conjugated drug substances.

Pursuant to the 2023 Lonza DMSA, Lonza will perform manufacturing process development and the manufacture of components for our PCV candidates, including the polysaccharide antigens, our proprietary eCRM protein carrier and conjugated drug substances.

Subject to the terms and conditions set forth in the 2023 Lonza DMSA, Lonza has granted to us a non-exclusive, worldwide, fully paid-up, transferable license, including the right to grant sublicenses (subject to the prior written consent of Lonza), under the New General Application Intellectual Property, to use, sell and import the Product manufactured under the 2023 Lonza DMSA (but no other products).

7 unchanged sentences

Commercial Manufacturing and Supply Agreement

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

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”).

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).

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).

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 Commercial Manufacturing and Supply Agreement.

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.

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.

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 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, 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 70,000,000, 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 27,000,000 that will be credited back to us over a 10-year period starting upon commencement of commercial production.

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.

2026 Development and Manufacturing Services Agreement

On February 18, 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.

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.

Sutro Biopharma Agreements

Amended and Restated License Agreement with Sutro Biopharma

Amended and Restated License Agreement

We are party to an amended and restated license agreement with Sutro Biopharma, dated October 12, 2015, which was subsequently amended on May 9, 2018, May 29, 2018, September 28, 2023 and November 21, 2023 (as amended, the “Sutro Biopharma License Agreement”).

2 unchanged sentences

In consideration of the rights granted under the Sutro Biopharma License Agreement, we are obligated to pay Sutro Biopharma a 4% royalty on worldwide aggregate annual net sales of our vaccine products for human health and a 2% royalty on such net sales of vaccine products for animal health.

Such royalty rates are

subject to specified reductions, including standard reductions for third-party payments and for expiration of relevant patent claims.

Such royalty rates are subject to specified reductions, including standard reductions for third-party payments and for expiration of relevant patent claims.

We are also obligated to pay Sutro Biopharma any royalties due to Stanford University (the upstream licensor of Sutro Biopharma), to the extent the royalties payable by Sutro Biopharma to Stanford University are greater than the royalties payable by us to Sutro Biopharma.

6 unchanged sentences

The agreement may be terminated by either party for the other party’s material breach uncured within 60 days’ notice, by us at will with 60 days’ notice, or by Sutro Biopharma if we challenge Sutro Biopharma’s patents or if we undergo a change of control with a specified competitor of Sutro Biopharma.

Supply Agreement with Sutro Biopharma

Supply Agreement

In May 2018, we entered into a supply agreement with Sutro Biopharma, which was subsequently amended on February 22, 2021 and November 21, 2023 (as amended, the “Sutro Biopharma Supply Agreement”) pursuant to which we purchase from Sutro Biopharma extract and custom reagents for use in manufacturing non-clinical and certain clinical supply of vaccine compositions utilizing the technology licensed under the Sutro Biopharma License at prices not to exceed a specified percentage above Sutro Biopharma’s fully burdened manufacturing cost.

3 unchanged sentences

In December 2019, we exercised our right to require Sutro Biopharma to establish a second supplier for extract and custom reagents to support our anticipated clinical and commercial needs.

Option Agreement with Sutro Biopharma

Option Agreement

In December 2022, we entered into an option grant agreement with Sutro Biopharma (the “Option Agreement”).

2 unchanged sentences

We and Sutro Biopharma agreed to negotiate the terms and conditions of a form definitive agreement to be entered into in the event we exercise the Option, which would include the terms and conditions set forth in an executed term sheet between us (the “Term Sheet”) and such terms that were necessary to give effect to each of the terms and conditions set forth in the Term Sheet (the “Form Definitive Agreement”).

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 on October 2, 2023 within five business days after we and Sutro

Biopharma mutually agree in writing upon the Form Definitive Agreement on September 28, 2023.

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.

On November 21, 2023 (the “Option Exercise Date”), we exercised the Option 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, followed by the second and final installment of $ 25.0 million in cash on May 13, 2024.

On November 21, 2023 (the “Option Exercise Date”), we exercised the Option 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, followed by the second and final installment of $25.0 million in cash in May 2024.

Upon the occurrence of certain regulatory milestones, certain additional milestone payments may total up to $60.0 million in cash.

In the event that we undergo a change of control, certain rights and payments may be accelerated.

Manufacturing Rights Agreement with Sutro Biopharma

Manufacturing Rights Agreement

Concurrent with the payment of the first installment of the Option exercise price pursuant to the Option Agreement, on November 21, 2023, the manufacturing rights agreement (in the form of the Form Definitive Agreement) between us and Sutro Biopharma (the “Manufacturing Rights Agreement”) became effective.

7 unchanged sentences

Unless earlier terminated, the Manufacturing Rights Agreement will remain in effect in perpetuity.

Sutro Biopharma may only terminate the Manufacturing Rights Agreement in the event of our (i) uncured, intentional, material breach of certain confidentiality provisions resulting in actual, material harm to Sutro Biopharma’s business, (ii) uncured, intentional material breach of certain provisions relating to the use of certain of Sutro Biopharma’s know-how outside of the Vaccine Field, (iii) unintentional, material breach of certain provisions relating to the use of certain of Sutro Biopharma’s know-how outside of the Vaccine Field that we do not use reasonable best efforts to cease and (to the extent reasonably curable) cure in a timely fashion, or (iv) uncured failure to pay the Option exercise price or any undisputed milestone payment under the Option Agreement when due.

how outside of the Vaccine Field that we do not use reasonable best efforts to cease and (to the extent reasonably curable) cure in a timely fashion, or (iv) uncured failure to pay the Option exercise price or any undisputed milestone payment under the Option Agreement when due.

We may terminate the Manufacturing Rights Agreement at our discretion upon 60 days’ written notice, and both parties may terminate the Manufacturing Rights Agreement upon mutual written consent.

Thermo Fisher Scientific Agreement

Commercial Manufacturing and Supply Agreement

In September 2025, we entered into a master services agreement with Thermo Fisher, pursuant to which Thermo Fisher will formulate, fill, inspect, package, label, test, manufacture and supply drug product for us at Thermo Fisher’s facility in Greenville, North Carolina (the "Thermo Fisher Commercial Manufacturing and Supply Agreement").

Pursuant to the Thermo Fisher Commercial Manufacturing and Supply Agreement, we have agreed to order drug product from Thermo Fisher based on certain binding forecast periods and established prices.

In addition, we will also pay Thermo Fisher for technology transfer activities and reimburse Thermo Fisher for certain out-of-pocket capital expenditures under the terms of the agreement.

The Thermo Fisher Commercial Manufacturing and Supply Agreement has an initial term of 15 years and will automatically renew for additional three-year periods unless either party provides notice of non-renewal before the end of the then existing term, subject to completion of ongoing services.

We are permitted to terminate the Thermo Fisher Commercial Manufacturing and Supply Agreement prior to expiration, subject to the payment of applicable termination fees, plus certain capital expenditure commitments.

University of California, San Diego License Agreement

7 unchanged sentences

Such royalty rate is subject to standard reductions for third-party payments.

Royalties are payable until expiration of

the last licensed patent.

Royalties are payable until expiration of the last licensed patent.

Additionally, in the event we sublicense commercial rights under the UCSD License, we are obligated to pay UCSD a percentage of all sublicensing revenue received, excluding any earned royalties or reimbursements of research and development expenses, of 20% up to a maximum of $2.5 million.

8 unchanged sentences

Pfizer, Merck, GSK and Sanofi have been responsible for developing and introducing most new vaccines to the world.

As a result of the COVID-19 pandemic, there have been a number of new entrants to the vaccines market, including multinational companies and emerging biopharmaceutical companies.

Other pharmaceutical and biotechnology companies, academic institutions, governmental agencies and public and private research institutions are also working towards new solutions given the continuing global unmet medical need.

Within the current pneumococcal vaccine market, Pfizer, Merck and GSK have comprised the significant majority of market share and sales, with Pfizer’s PCV13 and PCV20, Merck’s PPSV23, PCV15 and PCV21 and GSK’s Synflorix totaling a combined $7.8 billion in global pneumococcal vaccine sales in 2024 (approximately 82%, 14% and 4%, of such sales for these three products, respectively).

Other pharmaceutical and biotechnology companies, academic institutions, governmental

agencies and public and private research institutions are also working towards new solutions given the continuing global unmet medical need.

Within the current pneumococcal vaccine market, Pfizer, Merck and GSK have comprised the significant majority of market share and sales, with Pfizer’s PCV13 and PCV20, Merck’s PPSV23, PCV15 and PCV21 and GSK’s Synflorix totaling a combined $8.5 billion in global pneumococcal vaccine sales in 2025 (approximately 77%, 21% and 2%, of such sales for these three product families, respectively).

Existing vaccine makers, as well as new entrants, are competing to develop the next generation of pneumococcal vaccines.

8 unchanged sentences

In infants, the current standard-of-care consists of the administration of either PCV20 or PCV15 alone.

Pfizer announced in October 2024 that it is developing a 25-valent PCV candidate that is currently in adult and pediatric Phase 2 clinical trials, and that it is working on a 30-plus valent PCV candidate that is in preclinical development.

Sanofi and SK Chemicals have partnered to develop a 21-valent PCV and, in June 2023, announced positive results from their Phase 2 clinical trials in infants.

In December 2024, Sanofi and SK Chemicals announced the initiation of a global pediatric Phase 3 clinical study of their 21-valent PCV candidate, as well as an expanded agreement to develop, license and commercialize "next-generation" PCVs for both pediatric and adult populations.

GSK, which previously acquired Affinivax, is developing a 24-valent affinity-bound pneumococcal vaccine for infants, which is currently in a pediatric Phase 2 clinical trial with data anticipated in 2026 or later.

In October 2024, GSK announced they ceased the development of their 24-valent program in adults in favor of a preclinical 30-plus valent candidate.

The biotechnology company Inventprise is developing a 25-valent PCV (“PCV25”) that is currently in a Phase 1/2 clinical study in young adults being conducted in Canada.

In January 2024, Inventprise announced that it completed dosing in its Phase 2 study of PCV25 in adults aged 18-49 years old, and that pending the results from that study, it anticipates initiating a Phase 2 study in infants in midyear 2024 and a Phase 2 study in older adults in the second half of 2024.

Pfizer announced in 2024 that it is developing a 25-valent PCV candidate that is currently in adult and pediatric Phase 2 clinical trials, and that it is working on a 30-plus valent PCV candidate that is in preclinical development.

Pfizer announced in November 2025 that it plans to initiate adult and pediatric pivotal trials evaluating PCV25 in 2026.

In September 2025, Merck announced positive results from its Phase 3 study evaluating PCV21 in children aged 2–17 with increased risk for pneumococcal disease.

Merck is also advancing additional next-generation PCV candidates through multiple early-phase clinical studies evaluating different formulations.

GSK, which previously acquired vaccine developer Affinivax, was previously developing a 24‑valent affinity‑bound pneumococcal vaccine candidate in adults and infants.

In October 2024, GSK announced the termination of its adult 24-valent program in favor of a preclinical 30-plus valent candidate.

In October 2025, GSK announced the initiation of a Phase 1 study in Australia evaluating its 30-plus valent candidate in adults.

In the fourth quarter of 2025, GSK removed its pediatric 24-valent candidate, which had previously advanced into a Phase 2 clinical trial program, from its publicly disclosed pipeline.

Sanofi and SK bioscience have partnered to develop a 21-valent PCV and, in June 2023, announced positive results from their Phase 2 clinical trials in infants.

In December 2024, Sanofi and SK bioscience announced the initiation of a global pediatric Phase 3 clinical program of their 21-valent PCV candidate, as well as an expanded agreement to develop, license and commercialize "next-generation" PCVs for both pediatric and adult populations.

In February 2026, SK bioscience announced that it expected topline results from this Phase 3 study to be available in 2027, and that a next-generation PCV candidate, also co-developed with Sanofi, was in preclinical development with clinical trial entry expected in 2026.

We believe success will ultimately be based on the combination of several factors, including the broadest coverage of serotypes, disease coverage, immunogenicity, boostability, safety and tolerability.

4 unchanged sentences

However, the FDA lifted a 30-year ban on Group A Strep vaccine clinical trials in 2005, and research has slowly started to resurface, mostly in academic institutions.

However, we are not aware of other Group A Strep vaccines in clinical development that would cover all strains of the bacteria.

The GSK Vaccines Institute for Global Health is currently working on a preclinical vaccine candidate.

We are not aware of any other vaccines under clinical development to treat periodontitis.

We believe the success of our vaccine candidates in these areas will be based on potential efficacy, safety, tolerability, convenience and pricing.

We are aware of some companies developing treatments for other diseases that target the same underlying pathogens that cause Group A Strep, periodontitis and Shigella.

Based on publicly available information, a limited number of Group A Strep vaccine candidates are in development, including programs at the GSK Vaccines Institute for Global Health which is in a preclinical stage, Moderna which has a candidate in a Phase 1 study, and Griffith University which has an ongoing Phase 1/2 clinical study in healthy adults, as well as other early-stage efforts including VaxForm and BioMVis that have been described as preclinical or otherwise early in development.

We are not aware of any Group A Strep vaccine candidate in clinical development that is designed to provide broad coverage across all Group A Strep strains.

Competition in this area is expected to be based on clinical profile and development progress, including potential efficacy, safety and tolerability,

dosing regimen and convenience, manufacturing feasibility, and pricing and access dynamics.

In addition, we are aware that some companies are developing therapeutic approaches for Group A Strep-associated diseases that may overlap with certain clinical or commercial segments targeted by Group A Strep vaccines.

Based on publicly available information, we are aware of a limited number of Shigella vaccine programs in clinical development, including candidates being advanced by Valneva and LimmaTech.

In addition, we are aware that some companies are developing therapeutics for other indications that target pathogens or biological mechanisms that may overlap with the underlying pathogens associated with Shigella, which could compete in certain patient populations or clinical settings.

Competition in this area is expected to be based on clinical profile and development progress, including potential efficacy, safety and tolerability, dosing regimen and convenience, manufacturing feasibility, and pricing and access dynamics.

Our commercial opportunity could be reduced or eliminated if our competitors develop and commercialize vaccines that are safer, more effective, more convenient, less expensive or with a more favorable label than VAX-31, VAX-24 or any other vaccine we may develop.

10 unchanged sentences

In addition, we cannot provide any assurance that any patents will be issued from our pending or future applications or that any issued patents will adequately protect our vaccine candidates.

Our patent portfolio as of February 25, 2025 contains five issued U.S.

Our patent portfolio as of February 24, 2026 contains four issued U.S.

patents and multiple issued international patents, multiple pending patent applications in the United States and internationally, and multiple pending patent cooperation treaty applications that are owned by us, as well as certain foreign counterparts of a subset of these patent applications in foreign countries, including Australia, Brazil, Canada, China, India, Israel, Japan, South Korea, Taiwan, Mexico, New Zealand, the Philippines, Singapore, South Africa and countries within the European Patent Convention and the Eurasian Patent Organization.

1 unchanged sentence

For our Group A Strep vaccine, these patent applications are directed to vaccine formulations, protein-antigen conjugates, vaccines and components thereof, as well as processes for their manufacture.

For our periodontitis vaccine, the patents and applications relate to vaccine formulations, protein antigens, and methods of using the vaccine.

If issued, the 20-year term expiration dates of our patents will expire between 2037 and 2043, not including any extension of the patent term that may be available in certain jurisdictions.

8 unchanged sentences

We seek to protect our proprietary information, including trade secrets, in part, by using confidentiality agreements with our commercial partners, collaborators, employees and consultants, and invention assignment agreements with our employees.

We also have confidentiality agreements or invention assignment agreements with our commercial partners and selected consultants.

We also have confidentiality agreements or invention assignment agreements with our commercial partners and selected

These agreements may be breached, and we may not have adequate remedies for any breach.

12 unchanged sentences

For Medicare beneficiaries, vaccines may be covered under either the Part B program or Part D depending on several criteria, including the type of vaccine and the beneficiary’s coverage eligibility.

If our vaccine candidates, once approved, are covered only under the Part D program, physicians may be less willing to use our products because of the claims adjudication costs and time related to the claims adjudication process and collection of co-payments associated with the Part D program.

Further, no uniform policy for coverage and reimbursement exists in the United States, and coverage and reimbursement can differ significantly from payor to payor.

18 unchanged sentences

• FDA review of the BLA and issuance of a biologics license, which is the approval necessary to market a vaccine.

Before conducting studies in humans, laboratory evaluation of product chemistry, toxicity and formulation, as well as animal studies to assess the potential safety and efficacy of the biologic candidate, must be conducted.

Preclinical toxicology studies in animals must be conducted in compliance with FDA regulations.

Before conducting studies in humans, laboratory evaluation of product chemistry, toxicity and formulation, and other nonclinical studies must be conducted.

Preclinical toxicology studies in animals must be conducted in compliance with applicable federal regulations and requirements, including good laboratory practices and the Animal Welfare Act and its implementing regulations.

The results of the preclinical tests, together with manufacturing information, known as CMC, and analytical data, are submitted to the FDA as part of an IND application.

9 unchanged sentences

Sponsors must also report to the FDA within specified timeframes, serious and unexpected adverse reactions, any clinically significant increase in the rate of a serious suspected adverse reaction over that listed in the protocol or investigator’s brochure or any findings from other studies or animal or in vitro testing that suggest a significant risk in humans exposed to the vaccine candidate.

An IRB at each institution participating in the clinical trial must review and approve the protocol

before a clinical trial commences at that institution, approve the information regarding the trial and the consent form that must be provided to each research subject or the subject’s legal representative and monitor the trial until completed.

An IRB at each institution participating in the clinical trial must review and approve the protocol before a clinical trial commences at that institution, approve the information regarding the trial and the consent form that must be provided to each research subject or the subject’s legal representative, and monitor the trial until completed.

Clinical trials are typically conducted in three sequential phases, but the phases may overlap, and different trials may be initiated with the same vaccine candidate within the same phase of development in similar or differing patient populations.

27 unchanged sentences

The FDA may also convene an advisory committee to provide clinical insight on application review questions.

The FDA is not bound

by recommendations of an advisory committee, but it considers such recommendations when making decisions regarding approval.

The FDA is not bound by recommendations of an advisory committee, but it considers such recommendations when making decisions regarding approval.

Before approving a BLA, the FDA will typically inspect the facility or facilities where the product is manufactured.

3 unchanged sentences

If the FDA determines that the application, manufacturing process or manufacturing facilities are not acceptable, it will outline the deficiencies in the submission and often will request additional testing or information.

Notwithstanding the submission of any requested additional information, the FDA ultimately may decide that the application does not satisfy the regulatory criteria for approval.

Notwithstanding the submission of

any requested additional information, the FDA ultimately may decide that the application does not satisfy the regulatory criteria for approval.

After the FDA evaluates a BLA and conducts inspections of manufacturing facilities where the investigational product and/or its drug substance will be produced, the FDA may issue an approval letter or a Complete Response Letter.

23 unchanged sentences

Failure to comply with the applicable U.S.

requirements at any time during the product development process, approval process or after approval, may subject an applicant or manufacturer to administrative or judicial civil or criminal sanctions and adverse publicity.

requirements at any time during the product development process, approval process or after approval, may

subject an applicant or manufacturer to administrative or judicial civil or criminal sanctions and adverse publicity.

FDA sanctions could include refusal to approve pending applications, withdrawal or suspension of an approval or license, clinical holds, warning or untitled letters, product recalls, product seizures, safety alerts, Dear Healthcare Provider letters, total or partial suspension of production or distribution, injunctions, fines, refusals of government contracts, mandated corrective advertising or communications with doctors, debarment, restitution, disgorgement of profits, consent decrees or civil or criminal penalties.

21 unchanged sentences

Priority review is granted when there is evidence that the proposed product would be a significant improvement in the safety or effectiveness of the treatment, diagnosis or prevention of a serious disease or condition.

If criteria are not met

for priority review, the application is subject to the standard FDA review period of 10 months after the FDA accepts the application for filing.

If criteria are not met for priority review, the application is subject to the standard FDA review period of 10 months after the FDA accepts the application for filing.

Priority review designation does not change the scientific/medical standard for approval or the quality of evidence necessary to support approval.

Under the accelerated approval program, the FDA may approve a BLA on the basis of either a surrogate endpoint that is reasonably likely to predict clinical benefit, or on a clinical endpoint that can be measured earlier than irreversible morbidity or mortality, that is reasonably likely to predict an effect on irreversible morbidity or mortality or other clinical benefit, taking into account the severity, rarity or prevalence of the condition and the availability or lack of alternative treatments.

Post-marketing studies or completion of ongoing studies after marketing approval are required to verify the biologic’s clinical benefit in relationship to the surrogate endpoint or ultimate outcome in relationship to the clinical benefit.

The Food and Drug Omnibus Reform Act and new FDA guidance, provide that confirmatory studies must be underway prior to approval of the BLA to gain approval under the accelerated approval pathway.

25 unchanged sentences

Among policymakers and payors in the United States, there is significant interest in promoting changes in healthcare systems with the stated goals of containing healthcare costs, improving quality and/or expanding access.

In the United States, the pharmaceutical industry has been a particular focus of these efforts and has been significantly affected by major legislative initiatives.

For example, in August 2022, then-President Biden signed the Inflation Reduction Act of 2022 (“IRA”) into law, which among other things, enables CMS to assert control over the prices of certain single-source drugs and biotherapeutics reimbursed under the Medicare Drug Price Negotiation Program, subjects drug manufacturers to potential civil monetary penalties and a significant excise tax for offering a price that is not equal to or less than the government-imposed “maximum fair price” under the law;

In the United States, the pharmaceutical industry has been a particular focus of these efforts and has been significantly affected by major

legislative initiatives.

For example, in August 2022, the Inflation Reduction Act of 2022 (“IRA”) was signed into law, which among other things, enables the Centers for Medicare & Medicaid Services (“CMS”) to assert control over the prices of certain single-source drugs and biotherapeutics reimbursed under the Medicare Drug Price Negotiation Program, subjects drug manufacturers to potential civil monetary penalties and a significant excise tax for offering a price that is not equal to or less than the government-imposed “maximum fair price” under the law;

imposes Medicare rebates for certain Part B and Part D drugs where relevant pricing metrics associated with the products increase faster than inflation;

2 unchanged sentences

Further, as of January 1, 2023, the IRA eliminates patient cost sharing for FDA-approved adult vaccines that are recommended by the ACIP and covered under Medicare Part D and mandates that all state Medicaid programs cover FDA-approved adult vaccines that are recommended by the ACIP and their administration without cost sharing as of October 1, 2023.

In addition, in November 2023, CMS released final guidance on the Part D Discount Program, which will require manufacturers to take on more of the beneficiary cost previously subsidized by the federal government through the application of increased drug discounts.

In addition, in December 2024, CMS released revised guidance on the Part D Manufacturer Discount Program, which requires manufacturers to take on more of the beneficiary cost previously subsidized by the federal government through the application of increased drug discounts.

The IRA does not change either VFC or the related provisions added in 2010 under the ACA.

2 unchanged sentences

In addition, certain vaccines, including pneumococcal virus vaccines, are excluded from the Medicare Part B inflation rebate.

CMS also has stated in guidance released on February 9, 2023, that it will not impose Medicare Part D inflation rebates at this time on vaccines and other drugs and biologics that are not “covered outpatient drugs” under Medicaid or otherwise do not have an obligation to report drug pricing data to Medicaid.

CMS also has stated in guidance and rulemaking that it is not imposing Medicare Part D inflation rebates at this time on vaccines and other drugs and biologics that are not “covered outpatient drugs” under Medicaid or otherwise do not have an obligation to report drug pricing data to Medicaid.

Additionally, the IRA contains a limited small biotech exception, which applies on a drug-specific basis, and qualifying drugs may be exempt from possible pricing negotiation through 2028 and eligible for a lower limit (i.e., a price floor) on the potential maximum fair price in 2029 and 2030, if the manufacturers of those drugs continue to qualify each year.

On January 17, 2025, CMS announced the list of the next fifteen Medicare Part D drugs selected for negotiation under the IRA.

It is unclear how the IRA will be effectuated or changed under the current U.S.

administration.

By February 1 of each year, CMS announces the list of the next Medicare Part B and Part D drugs selected for negotiation under the IRA.

Prior to the IRA, in March 2010, the ACA was passed, which substantially changed the way healthcare is financed by both the government and private insurers and significantly impacts the U.S.

6 unchanged sentences

(v) created a new Patient-Centered Outcomes Research Institute to oversee, identify priorities in, and conduct comparative clinical effectiveness research, along with funding for such research;

(vi) created a new Medicare Part D coverage gap discount program, in which manufacturers must now agree to offer 70% point-of-sale discounts off negotiated prices of applicable brand drugs to eligible beneficiaries during their coverage gap period, as a condition for the manufacturer’s outpatient drugs to be covered under Medicare Part D;

and (vii) established a Center for Medicare & Medicaid Innovation at the Centers for Medicare & Medicaid Services (“CMS”) to test innovative payment and service delivery models to lower Medicare and Medicaid spending, potentially including prescription drugs.

There have been judicial and political challenges to certain aspects of the ACA.

By way of example, the Tax Cuts and Jobs Act of 2017 (the “Tax Act”) was signed into law and included a provision repealing, effective January 1, 2019, the tax-based shared responsibility payment imposed by the ACA on specific individuals who fail to maintain qualifying health coverage for all or part of a year that is commonly referred to as the “individual mandate.” The Bipartisan Budget Act of 2018, among other things, amends the ACA, effective January 1, 2019, to close the coverage gap in most Medicare drug plans, commonly referred to as the “donut hole.” On June 17, 2021, the U.S.

Supreme Court dismissed a challenge on procedural grounds that argued the ACA is unconstitutional in its entirety because the "individual mandate" was repealed

More recently, a challenge to the ACA is advancing in federal courts.

(vi) created a new Medicare Part D coverage gap discount program which the IRA replaced, in which manufacturers were required to offer 70% point-of-sale discounts off negotiated prices of applicable brand drugs to eligible beneficiaries during their coverage gap period, as a condition for the manufacturer’s outpatient drugs to be covered under Medicare Part D (as discussed above, the IRA replaced this program with the Part D Manufacturer Discount Program effective January 1, 2025);

and (vii) established a Center for Medicare & Medicaid Innovation at the CMS to test innovative payment and service delivery models to lower Medicare and Medicaid spending, potentially including prescription drugs.

There have been judicial and legislative challenges to certain aspects of the ACA.

By way of example, the Tax Cuts and Jobs Act of 2017 (the “Tax Act”) was signed into law and included a provision repealing, effective January 1, 2019, the tax-based shared responsibility payment imposed by the ACA on specific individuals who fail to maintain qualifying health coverage for all or part of a year that is commonly referred to as the “individual mandate.” The Bipartisan Budget Act of 2018, among other things, amended the ACA, effective January 1, 2019, to close the coverage gap in most Medicare drug plans, commonly referred to as the “donut hole.” On June 17, 2021, the U.S.

Supreme Court dismissed a challenge on procedural grounds that argued the ACA is unconstitutional in its entirety because the "individual mandate" was repealed by Congress.

More recently, a challenge to the ACA advanced to the U.S.

Supreme Court.

Specifically, in Braidwood Management v.

Becerra, the plaintiffs argue that the ACA’s requirement that insurance cover certain preventive services without cost sharing is unconstitutional.

Becerra, the plaintiffs argued that the ACA’s requirement that insurance cover certain preventive services without cost sharing is unconstitutional.

In March 2023, the judge struck down the requirement with immediate nationwide effect by ruling, in part, that members of a panel charged under the ACA with recommending preventative services coverage had been appointed in an unconstitutional manner.

1 unchanged sentence

Court of Appeals for the Fifth Circuit (Fifth Circuit) held, among other things, that the ACA’s requirement that group health plans and health insurance issuers cover certain preventative services without cost-sharing is unconstitutional.

Supreme Court recently announced its decision to grant the government’s petition for certiorari in the case.

After granting the government’s petition for certiorari in the case, the U.S.

Supreme Court announced its decision in June 2025 upholding the constitutionality of the ACA’s preventive‑services mandate.

Other legislative and executive changes have been proposed or adopted since the ACA was enacted.

For example, on August 2, 2011, the Budget Control Act of 2011 was signed into law, which, among other things, resulted in aggregate reductions of Medicare payments to providers of 2% per fiscal year, which went into effect on April 1, 2013 and, due to subsequent legislative amendments to the statute, including the Infrastructure Investment and Jobs Act, will remain in effect through 2032, unless additional Congressional action is taken.

For example, on August 2, 2011, the Budget Control Act of 2011 was signed into law, which, among other things, resulted in aggregate reductions of Medicare payments to providers of 2% per fiscal year, which went into effect on April 1, 2013 and, due to subsequent legislative amendments to the statute, including the Infrastructure Investment and Jobs Act, will remain in effect through the first seven months of 2032, unless additional Congressional action is taken.

On January 2, 2013, the American Taxpayer Relief Act of 2012 was signed into law, which, among other things, reduced Medicare payments to several providers, including hospitals, and increased the statute of limitations period for the government to recover overpayments to providers from three to five years.

Further, on December 7, 2023, the Biden administration announced an initiative to control the price of prescription drugs through the use of march-in rights under the Bayh-Dole Act.

On December 8, 2023, the National Institute of Standards and Technology published for comment a Draft Interagency Guidance Framework for Considering the Exercise of March-In Rights which for the first time includes the price of a product as one factor an agency can use when deciding to exercise march-in rights.

March-in rights have not previously been exercised and it is uncertain if this initiative will continue under the current U.S.

administration.

At the state level, legislatures have increasingly passed legislation and implemented regulations designed to regulate pharmaceutical product pricing, including price or reimbursement constraints, discounts, restrictions on specific product access, marketing cost disclosure and transparency measures and, in some cases, measures designed to encourage importation from other countries and bulk purchasing.

On July 4, 2025, the One Big Beautiful Bill Act (“OBBBA”) was signed into law.

The OBBBA is projected to decrease federal health care spending by approximately $1 trillion by reducing Medicaid spending and enrollment and making changes to federal Medicare spending.

The law also made changes to ACA marketplace enrollment that are projected to decrease the number of individuals with marketplace coverage.

It is unclear if these changes will impact the pharmaceutical industry.

United States Healthcare Fraud and Abuse Laws and Compliance Requirements

Federal and state healthcare laws and regulations restrict certain business practices in the biopharmaceutical industry, including anti-kickback and false claims laws and regulations, data privacy and security laws and regulations and transparency laws and regulations.

The federal Anti-Kickback Statute prohibits, among other things, individuals or entities from knowingly and willfully offering, paying, soliciting or receiving remuneration, directly or indirectly, overtly or covertly, in cash or in-kind to induce or in return for purchasing, leasing, ordering or arranging for or recommending the purchase, lease or order of any item or service reimbursable under Medicare, Medicaid or other federal healthcare programs.

The federal Anti-Kickback Statute prohibits, among other things, individuals or entities from knowingly and willfully inducing or rewarding the referral of an individual, or offering, paying, soliciting or receiving remuneration, directly or indirectly, overtly or covertly, in cash or in-kind to induce or in return for purchasing, leasing, ordering or arranging for or recommending the purchase, lease or order of any item or service reimbursable under Medicare, Medicaid or other federal healthcare programs.

The term “remuneration” has been broadly interpreted to include anything of value.

A person or entity does not need to have actual knowledge of this statute or specific intent to violate it in order to have committed a violation.

The federal civil and criminal false claims laws, including the civil False Claims Act, and civil monetary penalties laws, prohibit, among other things, any individual or entity from knowingly presenting, or causing to be presented, a false claim for payment to the federal government or knowingly making, using or causing to be made or used a false record or statement material to a false or fraudulent claim to the federal government.

Private individuals, commonly known as “whistleblowers,” can bring civil False Claims Act qui tam actions, on behalf of the government and such individuals and may share in amounts paid by the entity to the government in recovery or settlement.

Federal civil and criminal false claims laws, including the civil False Claims Act, which prohibits, among other things, any individual or entity from knowingly presenting, or causing to be presented, a false claim for payment of government funds or knowingly making, using or causing to be made or used a false record or statement material to an obligation to pay or transmit money to the federal government, or knowingly concealing or improperly avoiding or decreasing an obligation to pay money to the federal government.

Private individuals, commonly known as “whistleblowers,” can bring civil False Claims Act qui tam actions, on behalf of the government and may share in amounts paid by the entity to the government in recovery or settlement.

In addition, the government may assert that a claim including items or services resulting from a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the civil False Claims Act.

The federal Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) created additional federal civil and criminal statutes that prohibit, among other things, knowingly and willfully executing a scheme to defraud any healthcare benefit program, including private third-party payors, or making any false, fictitious or fraudulent statement in connection with the delivery of or payment for healthcare benefits, items or services, including those by private payors.

Similar to the federal Anti-Kickback Statute, a person or entity does not need to have actual knowledge of the statute or specific intent to violate it in order to have committed a violation.

In addition, HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act, and their implementing regulations, imposes specific requirements relating to the privacy, security and transmission of protected health information on HIPAA covered entities, which include certain healthcare providers, health plans and healthcare clearinghouses and their business associates and covered subcontractors who conduct certain activities for or on their behalf involving protected health information on their behalf.

The federal Physician Payments Sunshine Act requires certain manufacturers of drugs, devices, biologics and medical supplies for which payment is available under Medicare, Medicaid or the Children’s Health Insurance Program, with specific exceptions, to report annually to CMS information related to payments or other transfers of value made to physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors), other healthcare professionals (such as physician assistants and nurse practitioners) and teaching hospitals, and applicable manufacturers and applicable group purchasing organizations to report annually to CMS ownership and investment interests held by physicians and their immediate family members.

Similar state, local and foreign healthcare laws and regulations may also restrict business practices in the pharmaceutical industry, such as state anti-kickback and false claims laws, which may apply to business practices, including, but not limited to, research, distribution, sales and marketing arrangements and claims involving healthcare items or services reimbursed by non-governmental third-party payors, including private insurers, or by patients themselves;

state laws that require pharmaceutical companies to comply with the pharmaceutical industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by the federal government, or otherwise restrict payments that may be made to healthcare providers and other potential referral sources;

(such as physician assistants and nurse practitioners) and teaching hospitals, and applicable manufacturers and applicable group purchasing organizations to report annually to CMS ownership and investment interests held by physicians and their immediate family members.

Similar state, local and foreign healthcare laws and regulations, such as state anti-kickback and false claims laws, may be broader in scope and may apply regardless of payor, in addition to items and services reimbursed under Medicaid and other state programs.

Additionally, there are state laws that require pharmaceutical companies to comply with the pharmaceutical industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by the federal government, or otherwise restrict payments that may be made to healthcare providers and other potential referral sources;

state laws and regulations that require drug manufacturers to file reports relating to pricing and marketing information or which require tracking gifts and other remuneration and items of value provided to physicians, other healthcare providers and entities;

2 unchanged sentences

Efforts to ensure compliance with applicable healthcare laws and regulations can involve substantial costs.

Violations of healthcare laws can result in significant penalties, including the imposition of significant civil, criminal and administrative penalties, damages, monetary fines, disgorgement, individual imprisonment, possible exclusion from participation in Medicare, Medicaid and other U.S.

Violations of federal and state healthcare laws described above can result in significant penalties, including, without limitation, the imposition of significant civil, criminal and administrative penalties, damages, monetary fines, disgorgement, individual imprisonment, exclusion from participation in Medicare, Medicaid and other U.S.

healthcare programs, integrity oversight and reporting obligations, contractual damages, reputational harm, diminished profits and future earnings and curtailment or restructuring of operations.

16 unchanged sentences

• The Community MA, which is issued by the European Commission through the Centralized Procedure, based on the opinion of the Committee for Medicinal Products for Human Use of the EMA, and which is valid throughout the entire territory of the EEA.

The Centralized Procedure is mandatory for certain types of products, such as biotechnology medicinal products, orphan medicinal products, advanced therapy products and medicinal products containing a new active substance indicated for the treatment certain diseases, such as AIDS, cancer, neurodegenerative disorders, diabetes, auto-immune and viral diseases.

The Centralized Procedure is mandatory for certain types of products, such as biotechnology medicinal products, orphan medicinal products, advanced therapy products and medicinal products

containing a new active substance indicated for the treatment certain diseases, such as AIDS, cancer, neurodegenerative disorders, diabetes, auto-immune and viral diseases.

The Centralized Procedure is optional for products containing a new active substance not yet authorized in the EEA, or for products that constitute a significant therapeutic, scientific or technical innovation or which are in the interest of public health in the EU;

17 unchanged sentences

In addition, numerous U.S.

states — including California, Colorado, Connecticut, Montana, Oregon, Utah, Texas, and Virginia — have enacted comprehensive data privacy laws in the past few years, and other U.S.

states, including Washington state, have enacted consumer health data privacy laws.

states — including, but not limited to California, Colorado, Connecticut, Montana, Oregon, Utah, Texas, and Virginia — have enacted comprehensive data privacy laws in the past few years, and other U.S.

states, including Washington and Nevada, have enacted consumer health data privacy laws.

Certain privacy and data protection laws and regulations, including HIPAA, establish standards for the protection of certain health information and impose requirements relating to the use, disclosure, and safeguarding of individually identifiable health information by covered entities and their business associates.

Foreign data privacy and security laws (including, but not limited to, the EU GDPR and UK GDPR) may impose significant and complex compliance obligations on entities that are subject to those laws.

2 unchanged sentences

temporary or definite bans on processing of personal data and other corrective actions;

fines of up to €20,000,000 or up to 4% of the total worldwide annual turnover of the preceding financial year, whichever is higher, and other administrative penalties;

fines of up to €20,000,000 or up to 4% of the total worldwide annual turnover of the preceding financial year,

whichever is higher, and other administrative penalties;

or private litigation related to processing of personal data brought by classes of data subjects or consumer protection organizations authorized at law to represent their interests.

21 unchanged sentences

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 1. Business