Vaxcyte Q3 net loss widens to $297M as R&D rises
VAX-A1 is advancing to Stage 2 after an independent review of Stage 1 safety and tolerability data, with sequential enrollment beginning in the Low and Mid Dose cohorts.
Sentiment and the balance of points
Rhea-AI Sentiment reads the wording of the document, how positive or negative its language is on a 1 to 5 scale. The balance of points shown with the takes weighs what the document actually discloses, so the two can disagree, for example when a trial that missed its main goal is described in upbeat language.
Form Type
8-K
Rhea-AI Filing Summary
Vaxcyte, Inc. (PCVX) reported a third-quarter net loss of $297.1 million, compared with $212.8 million a year earlier. Research and development expenses were $270.3 million versus $209.9 million, and general and administrative expenses were $37.9 million versus $32.4 million.
In the pivotal adult Phase 3 OPUS-1 trial, VAX-31 met all prespecified co-primary immunogenicity endpoints and had a safety profile similar to PCV20 and PCV21 across all ages studied. It met individual noninferiority criteria for 20 of 20 serotypes shared with PCV20 and 17 of 19 shared with PCV21; serotypes 3 and 12F did not meet the prespecified PCV21 LBCI >0.667 criterion but met the historical LBCI >0.5 threshold. October offerings generated $1.15 billion in gross and approximately $1.1 billion in net proceeds. Cash, cash equivalents and investments were $2,264.4 million as of September 30, 2026; pro forma including October net proceeds, they were approximately $3.4 billion. OPUS-2 and OPUS-3 results are expected in the first half of 2027, supporting a planned BLA submission in the first half of 2028.
1 point · 1 major0 major · 2 points
How this balance works
Rhea-AI gives every point it takes from this document a weight. Minor counts 1, Moderate 3 and Major 9, so one Major point outweighs several Minor ones. The bar adds up the weights on each side, and when neither side holds more than 65% of the total the balance reads Mixed.
It reads the document as published, with the same rules for every company, and it does not look at what the market expected or at how the stock traded, so a point can be objectively good on a day the stock falls.
Rhea-AI Sentiment measures something else, the tone of the wording.
Positive
- Major pointVAX-31 met noninferiority criteria for all 28 shared serotypes in OPUS-1.
Negative
- Moderate pointQuarterly net loss was $297.1 million, versus $212.8 million a year earlier.
- Minor pointTwo serotypes did not meet the prespecified PCV21 noninferiority criterion.
Filing Explained
The completed October financing paired a $575 million stock-and-warrant leg with $575 million of 1.50% notes due October 2032.
The completed October offerings comprised
VAX-A1 is advancing to Stage 2 after an independent review of Stage 1 safety and tolerability, but plans to initiate Stage 2 are still being completed. Enrollment is planned to proceed sequentially in the low- and mid-dose groups; the high-dose group is assigned to a new Stage 3 after prespecified safety assessments and further review and approval. The updated design adds a third vaccination for the low- and mid-dose groups, while the high-dose regimen remains two vaccinations.
8-K Event Classification
2 items: 2.02, 9.01
2 items
Item 2.02
Results of Operations and Financial Condition
Financial
Disclosure of earnings results, typically an earnings press release or preliminary financials.
Item 9.01
Financial Statements and Exhibits
Exhibits
Financial statements, pro forma financial information, or exhibit attachments filed with this report.
Key Figures
Net loss: $297.1 million
Research and development expenses: $270.3 million
General and administrative expenses: $37.9 million
+5 more
8 metrics
Net loss
$297.1 million
Three months ended September 30, 2026; compared with $212.8 million in 2025
Research and development expenses
$270.3 million
Three months ended September 30, 2026; compared with $209.9 million in 2025
General and administrative expenses
$37.9 million
Three months ended September 30, 2026; compared with $32.4 million in 2025
Cash, cash equivalents and investments
$2,264.4 million
As of September 30, 2026
Aggregate gross proceeds
$1.15 billion
Concurrent offerings completed in October 2026
Aggregate net proceeds
Approximately $1.1 billion
Concurrent offerings completed in October 2026
Pro forma cash, cash equivalents and investments
Approximately $3.4 billion
As of September 30, 2026, including approximately $1.1 billion in October net proceeds
OPUS-1 participants
4,047 adults
Healthy, pneumococcal-naïve U.S. adults in the pivotal Phase 3 trial
Key Terms
noninferiority criterion, opsonophagocytic activity (OPA) geometric mean ratios, immunobridging endpoint, Biologics License Application (BLA), +2 more
6 terms
noninferiority criterion medical
"met the noninferiority criterion (LBCI >0.667)"
A pre-specified rule used in a noninferiority clinical trial that determines how much worse a new treatment can be compared with an active control and still be considered acceptably similar. The criterion is usually expressed as a numerical margin (the “noninferiority margin” or delta) and a statistical test (often a one-sided confidence interval or p-value) that must exclude differences larger than the margin; the margin must be justified on clinical and regulatory grounds and cannot be invented after seeing results, and a trial meeting a noninferiority criterion does not automatically demonstrate superiority unless a separate, pre-specified superiority analysis is satisfied.
opsonophagocytic activity (OPA) geometric mean ratios medical
"based on opsonophagocytic activity (OPA) geometric mean ratios"
immunobridging endpoint medical
"prespecified primary immunobridging endpoint"
Biologics License Application (BLA) regulatory
"planned Biologics License Application (BLA) submission"
A biologics license application (BLA) is a formal request to a government agency seeking approval to sell a biological medicine, such as vaccines or gene therapies, in the market. It is similar to a detailed report that proves the product is safe, effective, and manufactured properly. For investors, a BLA signifies a critical step toward commercial availability, often impacting a company's valuation and market prospects.
convertible senior notes financial
"offering of convertible senior notes"
Convertible senior notes are a type of loan that a company issues to investors, which can be turned into company shares later on. They are called "senior" because they are paid back before other debts if the company runs into trouble. This allows investors to earn interest like a loan but also have the chance to own part of the company if its value rises.
pre-funded warrants financial
"offering of common stock and pre-funded warrants"
Pre-funded warrants are financial instruments that give investors the right to purchase a company's stock at a set price, but with most or all of the purchase price paid upfront. They function like a coupon or gift card for stock, allowing investors to buy shares later at a fixed price, which can be beneficial if they want to avoid future price increases. This makes them important for investors seeking flexibility and certainty in their investment plans.
Earnings Snapshot
Net loss: $297.1 million
Three months ended September 30, 2026
Net loss
$297.1 million
Compared with $212.8 million for the three months ended September 30, 2025
Research and development expenses
$270.3 million
Compared with $209.9 million for the three months ended September 30, 2025
General and administrative expenses
$37.9 million
Compared with $32.4 million for the three months ended September 30, 2025
FAQ
AI-generated questions and answers. How Rhea-AI works. Not financial advice.
What was PCVX's net loss in the third quarter of 2026?
Vaxcyte reported a net loss of $297.1 million for the three months ended September 30, 2026, compared with $212.8 million in the same period of 2025. For the nine months ended September 30, 2026, net loss was $902.0 million versus $520.1 million.
How did VAX-31 compare with PCV21 in OPUS-1?
In the prespecified individual comparator analysis, VAX-31 met the LBCI >0.667 noninferiority criterion for 17 of 19 serotypes shared with PCV21. Serotypes 3 and 12F did not meet that criterion, but each met the historical LBCI >0.5 threshold.
What are the terms of Vaxcyte's October 2026 convertible notes offering?
The convertible senior notes offering was $575 million, bears interest at 1.50% per annum, and matures in October 2032. The concurrent $575 million common stock and pre-funded warrants offering brought aggregate gross proceeds to $1.15 billion.
AI-generated analysis. How Rhea-AI works. Not financial advice.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
_____________________________________________
FORM 8-K
_____________________________________________
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): November 4, 2026
_____________________________________________
(Exact name of Registrant as Specified in Its Charter)
_____________________________________________
| (State or Other Jurisdiction of Incorporation) | (Commission File Number) | (IRS Employer Identification No.) | ||||||
| (Address of Principal Executive Offices) | (Zip Code) | |||||||
Registrant’s Telephone Number, Including Area Code: (650 ) 837-0111
Not Applicable
(Former Name or Former Address, if Changed Since Last Report)
_____________________________________________
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) | |||||
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) | |||||
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) | |||||
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) | |||||
Securities registered pursuant to Section 12(b) of the Act:
Title of each class | Trading Symbol(s) | Name of each exchange on which registered | ||||||||||||
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company o
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. o
Item 2.02 Results of Operations and Financial Condition.
On November 4, 2026, Vaxcyte, Inc. issued a press release announcing its financial results for the quarter ended September 30, 2026. The full text of the press release is furnished as Exhibit 99.1 to this report on Form 8-K and is incorporated herein by reference.
The information in this Item 2.02 and Item 9.01, including Exhibit 99.1, shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference into any registration statement or other document filed under the Securities Act of 1933, as amended or the Exchange Act, except as shall be expressly set forth by specific reference in such filing.
Item 9.01 Financial Statements and Exhibits.
(d)Exhibits
| Exhibit Number | Description | |||||||
| 99.1 | Press Release of Vaxcyte, Inc., dated November 4, 2026 | |||||||
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) | |||||||
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
| VAXCYTE, INC. | |||||||||||
| Date: | November 4, 2026 | By: | /s/ Andrew Guggenhime | ||||||||
| Andrew Guggenhime President and Chief Financial Officer | |||||||||||
Exhibit 99.1
Vaxcyte Reports Third Quarter 2026 Financial Results and Provides Business Update
VAX-31 Adult Indication: Announced Positive Topline Data from OPUS-1 Pivotal Phase 3 Trial; VAX-31 Met All Prespecified Primary Endpoints, Was Well Tolerated and Demonstrated a Safety Profile Similar to PCV20 and PCV21 Across All Ages Studied
VAX-31 Adult Indication: Company Expects to Report Results from OPUS-2 and OPUS-3 Phase 3 Trials in First Half of 2027, Supporting Planned Biologics License Application Submission in First Half of 2028
VAX-31 Infant Indication: Topline Safety, Tolerability and Immunogenicity Data from Primary Immunization Series and Booster Dose of Phase 2 Dose-Finding Study Expected Either Sequentially or Together by End of First Half of 2027
Phase 1 Study of VAX-A1, the Company's Vaccine Candidate Designed to Provide Broad Protection Against Disease Caused by Group A Streptococcus, Advancing to Stage 2 in Adults
Pro Forma Cash, Cash Equivalents and Investments of Approximately $3.4 Billion as of September 30, 2026, Including Approximately $1.1 Billion in Net Proceeds from October 2026 Equity and Convertible Senior Notes Offerings
SAN CARLOS, Calif., November 4, 2026 – Vaxcyte, Inc. (Nasdaq: PCVX), a clinical-stage vaccine innovation company, today announced financial results for the third quarter ended September 30, 2026, and provided a business update.
“The positive topline results from OPUS-1 represent a significant milestone for Vaxcyte and our broad-spectrum pneumococcal conjugate vaccine (PCV) franchise,” said Grant Pickering, Chief Executive Officer and Co-Founder of Vaxcyte. “VAX-31 met all prespecified primary endpoints in this pivotal Phase 3 trial, which inaugurated a more stringent noninferiority standard, and we believe the results further support its potential best-in-class profile. With OPUS-1 serving as the foundation of our planned Biologics License Application (BLA), we remain on track to announce results from the OPUS-2 and OPUS-3 Phase 3 trials in the first half of next year and, together with a manufacturing consistency study, we expect to submit a BLA in the first half of 2028. For the VAX-31 infant indication, we expect to announce topline data from the primary immunization series and booster dose of the ongoing Phase 2 study, either sequentially or together, by the end of the first half of 2027.”
“Following our positive OPUS-1 results, we completed concurrent equity and convertible senior notes offerings, raising approximately $1.1 billion in net proceeds, to further strengthen our balance sheet and extend our cash runway,” said Andrew Guggenhime, President and Chief Financial Officer of Vaxcyte. “With approximately $3.4 billion in pro forma cash, cash equivalents and investments as of September 30, 2026, we are well positioned to support the potential U.S.
commercial launch of VAX-31 for adults and advance our other key initiatives, including the VAX-31 OPUS-2 and OPUS-3 adult Phase 3 studies, the VAX-31 infant Phase 2 study, scale-up of our manufacturing and supply chain, and our earlier stage pipeline including VAX-A1 and VAX-XL.”
Key Third Quarter and Recent Highlights
PCV Franchise Adult Indication:
Reported Positive Topline Data from OPUS-1, the Pivotal Adult Phase 3 Trial of VAX-31: In October 2026, the Company announced positive topline results from OPUS-1, which evaluated the safety, tolerability and immunogenicity of VAX-31, its next-generation 31-valent PCV candidate, for the prevention of invasive pneumococcal disease (IPD) and pneumococcal pneumonia. The randomized, double-blind, active-controlled trial evaluated VAX-31 in 4,047 healthy, pneumococcal-naïve1 U.S. adults, including 3,572 aged 50 years and older and 475 aged 18-49. The results will serve as the cornerstone of a planned BLA submission, which will be subject to U.S. Food and Drug Administration (FDA) review.
In the OPUS-1 trial, VAX-31 met all prespecified co-primary immunogenicity endpoints in adults 50 and older:
•All 28 VAX-31 serotypes shared with Prevnar 20® (PCV20) and/or Capvaxive® (PCV21) met the prespecified noninferiority criteria based on opsonophagocytic activity (OPA) geometric mean ratios (GMRs), using a lower bound of the 95% confidence interval (LBCI) >0.667.2
•For the 11 serotypes shared by VAX-31, PCV20 and PCV21, VAX-31 met all 11 primary noninferiority assessments based on OPA GMRs. For each serotype, the prespecified analysis required noninferiority against at least one comparator, with prespecified multiplicity adjustment.2
•For the nine serotypes only in VAX-31 and PCV20, all nine met the prespecified OPA GMR noninferiority criterion.3
•For the eight serotypes only in VAX-31 and PCV21, all eight met the prespecified OPA GMR noninferiority criterion.3
•The three serotypes unique to VAX-31 and cross-reactive serotype 20B met the OPA GMR superiority criterion (LBCI >2.0) with prespecified multiplicity adjustment.2
For the prespecified primary immunobridging endpoint, VAX-31 met the noninferiority criterion (LBCI >0.667) for all 324 serotype OPA GMR comparisons in adults aged 18-49 compared to adults aged 50-64.
In the study, VAX-31 was well tolerated and demonstrated a safety profile similar to PCV20 and PCV21 at all ages studied. No serious adverse events were considered to be related to study vaccines, and there were no study discontinuations due to adverse events.
In the prespecified individual comparator analyses, VAX-31 met the noninferiority criterion (LBCI >0.667)3 for 20 of 20 serotypes shared with PCV20 and 17 of 19 shared with PCV21. Compared to PCV21, serotypes 3 and 12F did not meet the LBCI >0.667 noninferiority criterion, but did meet the historical LBCI >0.5 threshold; compared to PCV20, VAX-31 met the LBCI >0.667 noninferiority criterion.5 Given current U.S. epidemiology, with the serotypes unique to PCV21 accounting for a larger share of adult disease than those unique to PCV20, the Company expects the comparison of VAX-31 to PCV21 to be a particular focus of FDA review.
OPUS-2 and OPUS-3 Phase 3 Results Expected in First Half of 2027, Supporting Planned BLA Submission in First Half of 2028: The OPUS-2 and OPUS-3 Phase 3 trials, which are fully enrolled, are designed to generate a broad and robust safety, tolerability and immunogenicity dataset as part of the OPUS Phase 3 program evaluating VAX-31 for the prevention of IPD and pneumococcal pneumonia. In addition, the Company is planning a manufacturing consistency study as the final Phase 3 study to enable the submission of the BLA.
•The OPUS-2 Phase 3 study, in which 1,390 participants were dosed, is evaluating the safety, tolerability and immunogenicity of VAX-31 when administered either concomitantly with or one month following administration of a licensed seasonal influenza vaccine in healthy, pneumococcal-naïve U.S. adults aged 50 years and older. 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.
•The OPUS-3 Phase 3 descriptive study, in which 752 participants were dosed, is evaluating the safety, tolerability and immunogenicity of VAX-31 in healthy U.S. adults aged 50 years and older who have previously received pneumococcal vaccination. Among other objectives, the study will evaluate responses to serotypes included in the lower-valency pneumococcal vaccines and the ability of VAX-31 to expand the breadth of serotype-specific immune responses.
Early-Stage Pipeline:
VAX-A1 Phase 1 Study in Adults Advancing to Stage 2: VAX-A1 is an investigational prophylactic vaccine candidate designed to provide broad protection against disease caused by Group A Streptococcus. The VAX-A1 Phase 1 study initiated in June 2026 is advancing to Stage 2 following the completion of an independent Data Safety Monitoring Board (DSMB) review of Stage 1 safety and tolerability data. The Company is completing plans to initiate Stage 2 including an updated study design that incorporates the DSMB’s recommendations for sequential enrollment, beginning with the Low and Mid Dose cohorts. Enrollment of the High Dose cohort will be part of a new Stage 3 and will follow completion of the prespecified safety assessments and further DSMB review and approval. The study design has also been updated to add a third vaccination at the Low and Mid Dose levels, while the High Dose regimen remains two vaccinations. These updates are consistent with the stepwise evaluation of safety, tolerability and dosing regimens in first-in-human vaccine development, which is designed to identify the dose that best balances immune response and tolerability.
The randomized, observer-blind, placebo-controlled, dose-escalation study is designed to enroll approximately 80 healthy adults aged 18 to 40 years in Australia. The primary objective is to assess safety and tolerability, with a secondary objective of evaluating immune responses. Participants will be followed for safety through six months after their last vaccination.
Financing:
Completed Public Offerings Generating $1.15 Billion in Gross Proceeds: In October 2026, the Company completed concurrent underwritten public offerings which generated an aggregate $1.15 billion in gross proceeds, consisting of a $575 million offering of common stock and pre-funded warrants and a $575 million offering of convertible senior notes which bear interest at 1.50% per annum and mature in October 2032. The offerings included the full exercise of the
underwriters’ options. Aggregate net proceeds were approximately $1.1 billion after underwriting discounts and commissions and estimated offering expenses.
Executive Leadership Team:
Appointed Chief Medical Officer and Chief Legal Officer: In September 2026, the Company announced the appointments of experienced industry leaders Luis Jodar, Ph.D., as Chief Medical Officer and David McAvoy, J.D., as Chief Legal Officer.
•Dr. Jodar has more than 30 years of experience in vaccine development and launch across industry, international health organizations and academia. He spent 17 years at Pfizer Inc., most recently as Senior Vice President and Chief Medical Officer for Vaccines and Infectious Diseases.
•Mr. McAvoy brings more than three decades of legal leadership in the biopharmaceutical industry to Vaxcyte. He joined the Company from Teva Pharmaceutical Industries Ltd., where he served as Executive Vice President and Chief Legal Officer.
Anticipated Program Milestones
Vaxcyte is advancing the clinical development of its pipeline programs with several key milestones anticipated:
VAX-31 Adult Indication
•Announce safety, tolerability and immunogenicity data from the OPUS-2 and OPUS-3 Phase 3 trials in the first half of 2027.
VAX-31 Infant Indication
•Announce topline safety, tolerability and immunogenicity data from the VAX-31 infant Phase 2 randomized, dose-finding study from both the primary three-dose immunization series and booster dose either sequentially or together by the end of the first half of 2027.
VAX-A1
•Announce topline data from the Phase 1 study in adults in the second half of 2027.
Upcoming Investor Conferences
Company management will participate in fireside chats and host one-on-one meetings at the following investor conferences. A live webcast of the fireside chats will be accessible through the Investors & Media section of the Company's website at http://investors.vaxcyte.com for approximately 30 days following each conference.
•Guggenheim Healthcare Innovation Conference, November 9-11: Fireside chat will take place live on Tuesday, November 10, at 1:00 p.m. ET / 10:00 a.m. PT.
•UBS Global Biopharma Conference, November 16-17: Presentation will take place live on Tuesday, November 17, at 4:00 p.m. GMT / 11:00 a.m. ET / 8:00 a.m. PT.
•Jefferies London Healthcare Conference, November 16-19: Fireside chat will take place live on Wednesday, November 18, at 9:00 a.m. GMT / 4:00 a.m. ET / 1:00 a.m. PT.
•Evercore Healthcare Conference, November 30 to December 2: Fireside chat will take place live on Tuesday, December 1, at 9:35 a.m. ET / 6:35 a.m. PT.
Third Quarter 2026 Financial Results
•Cash Position: Cash, cash equivalents and investments were $2,264.4 million as of September 30, 2026, compared to $2,442.6 million as of December 31, 2025. The approximately $1.1 billion in net proceeds from the October 2026 offerings are not included in the September 30, 2026 balance.
•Research & Development (R&D) Expenses: R&D expenses were $270.3 million for the three months ended September 30, 2026 as compared to $209.9 million for the same period in 2025. The increase was due primarily to higher development and product manufacturing costs associated with the Company's PCV programs, including manufacturing activities to support the potential future commercial launches and clinical trial expenses primarily related to the VAX-31 OPUS Phase 3 trials, as well as higher personnel expenses related to the growth in the number of R&D employees.
•General & Administrative (G&A) Expenses: G&A expenses were $37.9 million for the three months ended September 30, 2026 as compared to $32.4 million for the same period in 2025. The increase was due primarily to higher personnel expenses related to the growth in the number of G&A employees and professional and consulting services.
•Net Loss: For the three months ended September 30, 2026, net loss was $297.1 million, compared to $212.8 million for the same period in 2025.
About Vaxcyte
Vaxcyte is a vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases. VAX-31, a 31-valent PCV candidate being evaluated in the OPUS Phase 3 adult clinical program and in a Phase 2 infant clinical program, is being developed for the prevention of IPD and is the broadest-spectrum PCV candidate in the clinic today. VAX-24, a 24-valent PCV candidate, has generated positive Phase 2 clinical results in both adults and infants and is designed to cover more serotypes than any PCV on-market. VAX-31 and VAX-24 are designed to improve upon standard-of-care PCVs by covering the serotypes in circulation that cause a significant portion of IPD and are associated with high case-fatality rates, antibiotic resistance and meningitis, while maintaining coverage of previously circulating strains. VAX-XL, in earlier-stage development, also leverages the Company’s carrier-sparing, site-specific conjugation technology with the aim of further expanding coverage to deliver the broadest-spectrum candidate in the Company’s PCV franchise.
VAX-A1 is a prophylactic vaccine candidate designed to provide broad, strain-independent protection against disease caused by Group A Strep and is currently being evaluated in a Phase 1 clinical study in adults. Group A Strep remains a significant global cause of morbidity and mortality across both adult and pediatric populations and is a leading driver of antibiotic use, underscoring the substantial public health burden.
Vaxcyte is re-engineering the way highly complex vaccines are made through XpressCF®, its cell-free protein synthesis platform exclusively licensed from Sutro Biopharma, Inc. Unlike conventional cell-based approaches, the Company’s system for producing difficult-to-make proteins and antigens is intended to develop and deliver high-fidelity vaccines with enhanced immunological benefits. Vaxcyte’s pipeline also includes VAX-GI, a vaccine candidate designed to prevent Shigella. For more information, visit www.vaxcyte.com.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements related to the potential benefits of Vaxcyte’s carrier-sparing platform and vaccine candidates, including breadth of coverage, the ability to deliver potentially best-in-class vaccines and improve upon the standard-of-care; the design, timing, progress and expected results of Vaxcyte's clinical trials and regulatory plans along with the standards for review and licensure of vaccines and regulators accepting our study as designed; the Company’s planned BLA submission for VAX-31; the future commercialization of Vaxcyte’s PCV programs; Vaxcyte’s cash runway; and other statements that are not historical fact. The words “anticipate,” “believe,” “could,” “expect,” “intend,” “plan,” “may,” “on track,” “potential,” “should,” “would” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) convey uncertainty of future events or outcomes and are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These forward-looking statements are based on Vaxcyte’s current expectations and actual results and timing of events could differ materially from those anticipated in such forward-looking statements as a result of risks and uncertainties, including, without limitation, risks related to Vaxcyte’s product development programs, including development timelines, success and timing of chemistry, manufacturing and controls and related manufacturing activities, potential delays or inability to obtain and maintain required regulatory approvals for its vaccine candidates, and the risks and uncertainties inherent with preclinical and clinical development processes; the success, cost and timing of all development activities and clinical trials; and sufficiency of cash and other funding to support Vaxcyte’s development programs and other operating expenses. These and other risks are described more fully in Vaxcyte’s filings with the Securities and Exchange Commission (SEC), including its Quarterly Report on Form 10-Q filed with the SEC on November 4, 2026 or in other documents Vaxcyte subsequently files with or furnishes to the SEC. All forward-looking statements contained in this press release speak only as of the date on which they were made and are based on management’s assumptions and estimates as of such date, and readers should not rely upon the information in this press release as current or accurate after its publication date. Vaxcyte undertakes no duty or obligation to update any forward-looking statements contained in this release as a result of new information, future events or changes in its expectations.
# # #
Contacts:
Patrick Ryan, Executive Director, Corporate Affairs
Vaxcyte, Inc.
415-606-5135
media@vaxcyte.com
Jeff Macdonald, Executive Director, Investor Relations
Vaxcyte, Inc.
917-371-0940
investors@vaxcyte.com
1 Pneumococcal-naïve means no known history of invasive pneumococcal disease, pneumococcal pneumonia or receipt of a licensed or investigational pneumococcal vaccine.
2 Under the prespecified Hochberg multiplicity adjustment, each of the 11 shared-serotype noninferiority assessments and each of the four primary superiority assessments succeeds against PCV20 and/or PCV21 if the one-sided adjusted p-value is <0.025 against at least one comparator. The OPA GMR margin for primary endpoints is >0.667 for noninferiority and 2.0 for superiority.
3 For individual comparator-specific noninferiority assessments and the primary immunobridging assessment, the lower bound of the 95% confidence interval (LBCI) for the OPA GMR must exceed 0.667 to establish noninferiority.
4 31 vaccine serotypes plus cross-reactive serotype 20B.
5 In the prespecified individual comparator-specific noninferiority assessments of VAX-31 vs PCV21, the lower bounds of the 95% confidence intervals for the OPA GMRs for serotypes 3 and 12F exceeded 0.5 but did not meet the prespecified individual noninferiority criterion of LBCI >0.667. The historical LBCI >0.5 noninferiority comparison was a prespecified key secondary endpoint.
Vaxcyte, Inc.
Condensed Consolidated Statements of Operations
(in thousands, except share and per share amounts)
Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||||||||||
2026 | 2025 | 2026 | 2025 | ||||||||||||||||||||
Operating expenses: | |||||||||||||||||||||||
Research and development (1) | $ | 270,326 | $ | 209,933 | $ | 850,956 | $ | 552,246 | |||||||||||||||
General and administrative (1) | 37,948 | 32,447 | 105,943 | 97,146 | |||||||||||||||||||
Total operating expenses | 308,274 | 242,380 | 956,899 | 649,392 | |||||||||||||||||||
Loss from operations | (308,274) | (242,380) | (956,899) | (649,392) | |||||||||||||||||||
Other income, net: | |||||||||||||||||||||||
Interest income | 23,189 | 29,259 | 75,554 | 93,267 | |||||||||||||||||||
Other (expense) income | (11,977) | 291 | (20,641) | 36,004 | |||||||||||||||||||
Total other income, net | 11,212 | 29,550 | 54,913 | 129,271 | |||||||||||||||||||
Net loss | $ | (297,062) | $ | (212,830) | $ | (901,986) | $ | (520,121) | |||||||||||||||
Net loss per share, basic and diluted | $ | (1.99) | $ | (1.56) | $ | (6.25) | $ | (3.83) | |||||||||||||||
Weighted-average shares outstanding, basic and diluted | 148,908,274 | 136,196,512 | 144,337,459 | 135,975,586 | |||||||||||||||||||
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(1)Amounts include stock-based compensation expense as follows:
Research and development | $ | 24,074 | $ | 18,383 | $ | 66,897 | $ | 54,499 | |||||||||||||||
General and administrative | 17,026 | 16,923 | 53,408 | 48,349 | |||||||||||||||||||
Total stock-based compensation expense | $ | 41,100 | $ | 35,306 | $ | 120,305 | $ | 102,848 | |||||||||||||||
Vaxcyte, Inc.
Summary Consolidated Balance Sheet Data
(in thousands)
September 30, 2026 | December 31, 2025 | ||||||||||
Cash, cash equivalents and investments | $ | 2,264,385 | $ | 2,442,623 | |||||||
Total assets | 2,989,136 | 3,002,717 | |||||||||
Total stockholders' equity | 2,489,218 | 2,685,510 | |||||||||