Vaxcyte (PCVX) Company Report

Vaxcyte is engaging with the FDA on its pneumococcal conjugate vaccine programs, noting that a recently leaked memo regarding efficacy studies for vaccines is consistent with its existing development plans for both adult and infant populations.
The company plans to initiate a Phase 3 non-inferiority study for its 31-valent adult vaccine in December (2025), with results expected in 2026, aiming for a Biologics License Application (BLA) submission in 2027 and market entry in 2028.
For the infant population, Vaxcyte's 31-valent program Phase 2 study was modified to include higher doses, with data expected by the end of the first half of 2027. The infant market is estimated at $6 billion out of an $8 billion total market.
Vaxcyte reported a strong balance sheet with $2.7 billion at the end of September (2025), which is projected to fund operations until mid-2028, covering the adult VAX-31 program, infant programs, and manufacturing investments.

3 days ago

Transcript

Vaxcyte Provides Update on FDA Interactions, Vaccine Development, and Financial Outlook

PCVX

New Projects/Investments

Guidance Update

Product Launch

Vaxcyte views a recent FDA memo regarding vaccine development requirements as consistent with their existing plans for adult pneumococcal conjugate vaccines, including a post-market study, and states it does not change their development plans for adult or infant populations.
The company expects to initiate a non-inferiority study for its phase 3 adult program for a 31-valent vaccine in December 2025, with readouts anticipated in 2026 and potential market entry in 2028.
For infants, the 31-valent program's phase 2 study is expected to provide data by the end of the first half of 2027, with ongoing efforts to optimize dosing for future phase 3 trials.
Vaxcyte reported a strong balance sheet with $2.7 billion in cash at the end of September 2025, which is projected to fund operations until mid-2028, covering the adult VAX-31 program through potential launch and advancing infant programs.

3 days ago

Transcript

Vaxcyte Updates on Vaccine Development Programs and Financial Outlook

PCVX

New Projects/Investments

Guidance Update

Product Launch

Vaxcyte plans to initiate its Phase III non-inferiority study for the 31-valent adult vaccine in December 2025, with results expected in 2026, targeting a Biologics License Application (BLA) submission in 2027 and market entry in 2028.
The company's 31-valent infant program is currently enrolling patients in a modified Phase II study, with data anticipated by the end of the first half of 2027. Discussions suggest the possibility of an otitis media outcome study for infants, potentially avoiding a pneumococcal pneumonia outcome study requirement.
Vaxcyte maintains that a recently leaked FDA memo regarding vaccine development does not alter its existing development plans for either adult or infant populations, as their strategy aligns with the memo's content.
The company reported a strong balance sheet with $2.7 billion in cash at the end of September 2025, which is projected to fund operations through mid-2028, covering the adult Phase III program, infant program advancement, and manufacturing investments.

3 days ago

Transcript

Vaxcyte Provides Update on VAX-31 Clinical Programs and Financial Position

PCVX

New Projects/Investments

Guidance Update

Vaxcyte is advancing its 31-valent pneumococcal conjugate vaccine (VAX-31), with the adult program set to initiate Phase 3 clinical development in December 2025.
The company anticipates disclosing PD4 (booster) data for the VAX-31 infant study by the end of the first half of 2027.
The pneumococcal conjugate vaccine market is projected to grow from its current $8 billion-$10 billion run rate to $12 billion-$15 billion in the next 5-10 years, driven significantly by the adult segment.
Vaxcyte reported a strong balance sheet with $2.7 billion as of September 30, 2025, expected to fund operations into the middle of 2028, and is on track with a $300 million-$350 million dedicated manufacturing facility with Lonza, due for completion in early 2026.

Nov 19, 2025, 2:30 PM

Transcript

Vaxcyte to Initiate Adult VAX-31 Phase III Study in December 2025 and Provides Program Updates

PCVX

New Projects/Investments

Guidance Update

Vaxcyte plans to initiate its Phase III pivotal study for VAX-31 in adults in December 2025, following positive Phase II results that demonstrated superior coverage and immune responses compared to the 20-Valent vaccine.
The company expects to disclose Phase II PD4 (booster) data for its VAX-31 infant program by the end of the first half of 2027, with a potential earlier disclosure of PD3 data.
Vaxcyte has invested in a dedicated manufacturing facility with Lonza, costing $300 million-$350 million, which is on track for completion in early 2026 to support future product launches.
As of September 30, 2025, Vaxcyte reported $2.7 billion on its balance sheet, which is sufficient to fund operations and its Pneumococcal Conjugate Vaccine (PCV) programs into the middle of 2028.
Competitors such as Pfizer have pushed back the potential initiation of their 25-Valent program's Phase III to late 2026, while GSK's 30-plus valent program is in early Phase I development.

Nov 19, 2025, 2:30 PM

Transcript

Vaxcyte to Initiate VAX-31 Adult Phase 3 in December 2025, Reports Strong Financial Position

PCVX

New Projects/Investments

Guidance Update

Vaxcyte is set to initiate Phase 3 clinical development for its VAX-31 pneumococcal conjugate vaccine in adults in December 2025, following positive Phase 2 outcomes that showed superior coverage and immune responses compared to the standard of care 20-valent vaccine.
The company reported a strong financial position with $2.7 billion on its balance sheet as of September 30, 2025, which is sufficient to fund operations and advance programs into mid-2028.
The pneumococcal vaccine market, currently $8 billion-$10 billion, is projected to grow to $12 billion-$15 billion in the next five to ten years, with the adult segment potentially reaching a 50-50 split with infants.
Manufacturing for VAX-31 is progressing, with a dedicated facility with Lonza on track for completion in early 2026 at a cost of $300 million-$350 million, and a partnership with Thermo Fisher for fill-finish.

Nov 19, 2025, 2:30 PM

Transcript

Vaxcyte Provides Updates on Vaccine Programs, Commercial Readiness, and Financial Position

PCVX

New Projects/Investments

Product Launch

Guidance Update

Vaxcyte plans to initiate its 31-valent adult program Phase 3 study in December 2025, with top-line results expected in 2026 and full Phase 3 readouts in 2027.
The company reported robust results for its 24-valent infant program, showing strong immune responses and a dose-response profile, and continues to enroll subjects for its 31-valent infant program, with data expected by end of H1 2027 or in two installments starting end of 2026/early 2027.
Vaxcyte is preparing for commercial launches, having hired Mike Millett as Chief Commercial Officer and expecting its dedicated manufacturing facility with Lonza to be completed early 2026.
The company maintains a strong balance sheet with $2.7 billion in cash and equivalents as of September 2025, supporting its clinical programs and launch readiness.
Vaxcyte operates in an $8 billion pneumococcal vaccine market projected to grow to $12-$14 billion, and believes its 31-valent adult vaccine will cover approximately 95% of strains, positioning it competitively.

Nov 11, 2025, 7:30 PM

Transcript

Vaxcyte Reports Q3 2025 Financial Results and Provides Business Update

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Earnings

Guidance Update

New Projects/Investments

Vaxcyte reported a net loss of $212.8 million for the three months ended September 30, 2025.
As of September 30, 2025, cash, cash equivalents, and investments totaled $2.7 billion, which is expected to fund the current operating plan into mid-2028.
The company plans to initiate the VAX-31 adult pivotal, non-inferiority study in December 2025, with topline data anticipated in 2026, and announced final positive data from the VAX-24 infant Phase 2 dose-finding study.
Vaxcyte is establishing fill-finish manufacturing in North Carolina through a new agreement with Thermo Fisher Scientific Inc., representing a long-term commitment of up to $1 billion in manufacturing and services.
Mike Mullette was appointed Chief Commercial Officer in October 2025 to lead the commercialization strategy.

Nov 4, 2025, 9:08 PM

8-K

Vaxcyte Highlights Broad-Spectrum PCV Franchise and Strong Financial Position

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Product Launch

New Projects/Investments

Vaxcyte is advancing VAX-31 and VAX-24, broad-spectrum pneumococcal conjugate vaccines (PCVs), with VAX-31 designed to cover 94.9% of Invasive Pneumococcal Disease (IPD) in U.S. adults aged ≥50 years and 92% in U.S. children <5 years.
The company has a strategic manufacturing approach, including agreements with Lonza for key component production and Thermo Fisher Scientific for U.S. fill-finish manufacturing, to build capacity for global commercial markets.
As of September 30, 2025, Vaxcyte reported approximately $2.7 billion in cash, cash equivalents, and investments.
Clinical data for VAX-31 indicated robust immune responses for all 11 incremental serotypes and a safety profile similar to PCV20, while VAX-24 demonstrated good tolerability and met non-inferiority criteria for 21 of 24 serotypes in its Phase 2 infant study.
The pneumococcal vaccine market is considered highly attractive, with PCV13 and PCV20 generating combined annual sales of approximately $6.4 billion in 2024.

Nov 4, 2025, 9:00 PM

Presentation

Vaxcyte Provides Update on Vax 31 Clinical Development and Financial Position

PCVX

Product Launch

New Projects/Investments

Guidance Update

Vaxcyte's lead pneumococcal conjugate vaccine, Vax 31, is progressing to Phase 3 clinical development in adults, with the pivotal study initiating in Q4 2025 and potential market approval anticipated by 2028.
The company has also reinitiated enrollment in its Phase 2 Vax 31 infant study with an optimized dose, with primary series data expected by mid-2027 or potentially earlier.
Vaxcyte confirmed FDA approval of its manufacturing process for Phase 3, a crucial step for commercialization of the complex 31-valent vaccine.
With a strong balance sheet of $2.8 billion as of June 30, Vaxcyte has extended its cash runway to fund operations until 2028, aligning with the anticipated adult Vax 31 approval.

Sep 3, 2025, 8:00 PM

Earnings Transcripts

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