PCVX 最新10-Q变化

相对上期新增的文字 · 来源:10-Q · 2026-08-05

• •Advanced VAX-31 Adult Phase 3 Program: All three ongoing VAX-31 Phase 3 clinical trials (OPUS-1, OPUS-2 and OPUS-3) are now fully enrolled with 6,191 adults dosed in total, approximately 3,500 of whom received VAX-31. These studies, which were finalized in consultation and alignment with the FDA, a…

• manufacturing consistency study (e.g., a lot-to-lot study) as the final Phase 3 study to enable the submission of the BLA.

• •Initiated Phase 1 Study Evaluating VAX-A1, a Potential Best-in-Class Vaccine Candidate Designed to Provide Broad Protection Against Disease Caused by Group A Streptococcus: In June 2026, we announced that the first participant was dosed in the Phase 1, first-in-human study evaluating VAX-A1, an inv…

• •Appointment and Retirement of Directors: The Board of Directors has appointed two new members, Dr. Moncef Slaoui and Dr. John Markels, to replace retiring members, Mr. Jacks Lee and Dr. Heath Lukatch. We thank both retiring members for their considerable contributions during their service. Dr. Slao…

• Since our inception in November 2013, we have devoted substantially all of our resources to performing research and development, undertaking preclinical studies, advancing our vaccine candidates through clinical trials, enabling manufacturing activities in support of our product development efforts,…

相对上期删除的文字 · 来源:10-Q · 2026-05-06

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

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

• ◦OPUS-2: In January 2026, we announced the first patients had been dosed in this Phase 3 trial evaluating VAX-31 when administered concomitantly with a licensed seasonal influenza vaccine in pneumococcal-

• naïve adults aged 50 years and older. In March 2026, we announced we completed enrollment of this trial with 1,390 participants dosed.

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

相对上期删除的文字 · 来源:10-Q · 2026-05-06

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

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

相对上期新增的文字 · 来源:10-Q · 2026-08-05

• 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…

• FDA or comparable foreign regulatory authorities or in infant clinical studies. VAX-31 and VAX-24 will require additional clinical and non-clinical development, regulatory review and approval in multiple jurisdictions, substantial investment, access to sufficient clinical and commercial manufacturin…

• safer, more effective, more convenient, less expensive or with a more favorable label than any vaccine candidates that we may develop.

• occur, we may be forced to abandon our development efforts for a program or for multiple programs, which would materially harm our business and could potentially cause us to cease operations.

• If our contract manufacturers cannot successfully manufacture material that conforms to our specifications and the strict regulatory requirements of the FDA or comparable foreign regulatory authorities, or if they cannot pass a pre-approval inspection, we may not be able to rely on their manufacturi…

相对上期删除的文字 · 来源:10-Q · 2026-05-06

• 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…

• generate any revenue from product sales. We cannot provide any assurance that we will be able to successfully advance our PCV candidates through the development process.

• 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.

• Even if we receive FDA approval to market additional vaccine candidates, we cannot provide assurance that any such vaccine candidates will be successfully commercialized, widely accepted in the marketplace or more effective than other commercially available alternatives. In addition, we believe curr…

相对上期新增的文字 · 来源:10-Q · 2026-08-05

• Harp Dhaliwal, our Chief Technical Operations Officer, adopted a 10b5-1 Plan on April 6, 2026, with an effective date of August 5, 2026. Mr. Dhaliwal’s 10b5-1 Plan provides for the potential exercise and sale of up to 68,000 shares of our common stock, and expires on August 15, 2027, or upon the ear…

• During the three months ended June 30, 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).

相对上期删除的文字 · 来源:10-Q · 2026-05-06

• 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).