PCVX — what changed in the latest 10-Q

Text added vs the prior filing · source: 10-Q · 2026-05-06

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

• •In December 2025, following an FDA End-of-Phase 2 meeting, we announced that the first participants were dosed in a Phase 3 pivotal, non-inferiority trial ("OPUS-1") evaluating the safety, tolerability and immune responses of VAX-31 in healthy, pneumococcal-naïve (defined as having no known prior h…

• •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 sep…

• ▪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 otiti…

• ▪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 in…

Text removed vs the prior filing · source: 10-Q · 2025-11-04

• Based on these positive results and the totality of VAX-31 data in adults, we selected the VAX-31 High dose (all serotypes dosed at 3.3mcg or 4.4mcg) to advance to an adult Phase 3 program. We plan to initiate the Phase 3 pivotal, non-inferiority study in December 2025 and announce topline safety, t…

• •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 adults.

• post-dose 3 and post-dose 4, along with other key immunogenicity endpoints, including OPA.

• ▪VAX-31 is a 31-valent, broad-spectrum, carrier-sparing investigational PCV being developed for the prevention of IPD in not only adults, but also in children. VAX-31 is the broadest-spectrum PCV in the clinic designed to cover approximately 92% of IPD and 93% of acute otitis media due to Streptococ…

• •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 inf…

Text added vs the prior filing · source: 10-Q · 2026-05-06

• Our cash and cash equivalents as of March 31, 2026 and December 31, 2025 consisted of readily available checking and money market funds. As of March 31, 2026 and December 31, 2025, we also invested in U.S. Treasury securities, U.S. government agency securities, corporate debt, commercial paper, cert…

• following table shows the impact of a hypothetical 10% increase or decrease in interest rates on our net assets as of March 31, 2026 and our net loss for the three months ended March 31, 2026:

• The following table shows the impact of a hypothetical 10% increase or decrease in current exchange rates on our net assets as of March 31, 2026 and our net loss for the three months ended March 31, 2026:

• Impact on Net Loss for the Three Months Ended March 31, 2026

• As our foreign currency risk increases in the future, we will evaluate alternative strategies, including hedging, to mitigate our foreign currency exposure.

Text removed vs the prior filing · source: 10-Q · 2025-11-04

• Our cash and cash equivalents as of September 30, 2025 and December 31, 2024 consisted of readily available checking and money market funds. As of September 30, 2025 and December 31, 2024, we also invested in U.S. Treasury securities,

• U.S. government agency securities, corporate debt, commercial paper and asset-backed securities. Our primary exposure to market risk is interest rate sensitivity, which is affected by changes in the general level of U.S. interest rates. We do not believe that our cash and cash equivalents have signi…

• Impact on Net Loss for the Nine Months Ended September 30, 2025

• As our foreign currency risk increases in the future, we intend to evaluate alternative strategies, including hedging, to mitigate our foreign currency exposure.

• The rate of inflation in the United States has risen to levels not experienced in decades. Inflation generally affects us by increasing our cost of labor and research and development contract costs. The extent of any future impacts from inflation

Text added vs the prior filing · source: 10-Q · 2026-05-06

• We expect to continue to spend significant resources to fund research and development of, and seek regulatory approvals for, our vaccine candidates. We expect to incur substantial and increasing operating losses over the next several years as our research, development, manufacturing, preclinical tes…

• accumulated deficit will also increase significantly. We may encounter unforeseen expenses, difficulties, complications, delays and other unknown factors that may adversely affect our business. The size of our future net losses will depend, in part, on the rate of future growth of our expenses and o…

• Our ability to raise additional funds will depend on financial, economic and other factors, many of which are beyond our control. We cannot be certain that additional funding will be available on acceptable terms, or at all. We have no

• committed source of additional capital and if we are unable to raise additional capital in sufficient amounts or on terms acceptable to us, we may have to significantly delay, scale back or discontinue the development or commercialization of our vaccine candidates or other research and development i…

• Furthermore, our expectations with regard to our scalability and costs of manufacturing may vary significantly as we develop our vaccine candidates and learn more about these critical factors. Conjugate vaccine development is highly complex, and development of broad-valency pneumococcal conjugate va…

Text removed vs the prior filing · source: 10-Q · 2025-11-04

• We expect to continue to spend significant resources to fund research and development of, and seek regulatory approvals for, our vaccine candidates. We expect to incur substantial and increasing operating losses over the next several years as our research, development, manufacturing, preclinical tes…

• Our ability to raise additional funds will depend on financial, economic and other factors, many of which are beyond our control. We cannot be certain that additional funding will be available on acceptable terms, or at all. We have no committed source of additional capital and if we are unable to r…

• Furthermore, our expectations with regard to our scalability and costs of manufacturing may vary significantly as we develop our vaccine candidates and learn more about these critical factors. Conjugate vaccine development is highly

• As a result of these factors, our competitors may obtain regulatory approval of their products before we are able to, which may limit our ability to develop or commercialize our vaccine candidates, or achieve a competitive position in the market. This would adversely affect our ability to generate r…

• Mergers and acquisitions in the pharmaceutical and biotechnology industries may result in even more resources being concentrated among a smaller number of our competitors. Smaller and early-stage companies may also prove to be

Text added vs the prior filing · source: 10-Q · 2026-05-06

• The adoption, modification or termination of contracts, instructions or written plans for the purchase or sale of our securities by our Section 16 officers or directors for the three months ended March 31, 2026, each of which was entered into during an open trading window and is intended to satisfy …

• Grant Pickering, our Chief Executive Officer and a member of our Board, adopted a 10b5-1 Plan on March 3, 2026, with an effective date of June 2, 2026. Mr. Pickering’s 10b5-1 Plan provides for the potential sale of up to 44,473 shares of our common stock held by Mr. Pickering and the potential exerc…

• Andrew Guggenhime, our President and Chief Financial Officer, adopted a 10b5-1 Plan on March 4, 2026, with an effective date of June 3, 2026. Mr. Guggenhime’s 10b5-1 Plan provides for the potential exercise and sale of up to 156,000 shares of our common stock, and expires on June 30, 2027, or upon t…

• During the three months ended March 31, 2026, none of our other directors or Section 16 officers adopted, modified or terminated any Rule 10b5-1 trading arrangement or non-Rule 10b5-1 trading arrangement (as such terms are defined in Item 408 of Regulation S-K).

Text removed vs the prior filing · source: 10-Q · 2025-11-04

• During the three months ended September 30, 2025 none of our directors or Section 16 officers adopted, modified or terminated any Rule 10b5-1 trading arrangement or non-Rule 10b5-1 trading arrangement (as such terms are defined in Item 408 of Regulation S-K).