Vaxcyte (NASDAQ: PCVX) advances Phase 3 VAX-31 program and holds $2.7B cash
Filing Impact
Filing Sentiment
Form Type
8-K
Rhea-AI Filing Summary
Vaxcyte, Inc. reported first-quarter 2026 results and a broad clinical and manufacturing update. The company is fully enrolled in its three adult Phase 3 OPUS trials of VAX-31 and expects topline OPUS-1 data in the fourth quarter of 2026, with OPUS-2 and OPUS-3 results in the first half of 2027. An infant Phase 2 dose-finding study of VAX-31 has completed enrollment, with topline data from the primary series and booster expected by the end of the first half of 2027. Vaxcyte plans to start a Phase 1 adult trial of its Group A Strep vaccine candidate VAX-A1 in mid-2026. The company completed a February 2026 equity offering of 12,650,000 shares at $50.00 per share, contributing to $2.74 billion in cash, cash equivalents and investments as of March 31, 2026. First-quarter R&D expenses rose to $312.8 million, and net loss widened to $320.6 million, or $2.30 per share.
Positive
- None.
Negative
- None.
Insights
Vaxcyte ramps spending to advance late-stage vaccines while maintaining a very large cash buffer.
Vaxcyte is pivoting firmly into late-stage development. All three adult Phase 3 OPUS trials for VAX-31 are fully enrolled, and an infant Phase 2 study is underway, with key readouts clustered between the fourth quarter of 2026 and the first half of 2027.
The company completed a February underwritten offering of 12,650,000 shares at $50.00 per share, supporting a cash, cash equivalents and investments balance of $2.74 billion as of March 31, 2026. This underpins heavy R&D investment of $312.8 million in the quarter and a net loss of $320.6 million.
Commercial readiness is progressing through a large-scale Lonza manufacturing facility and a North Carolina fill-finish buildout. Actual outcomes will hinge on the OPUS-1, OPUS-2 and OPUS-3 data and subsequent regulatory review targeted around the 2026–2027 readout window described here.
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, and exhibit attachments filed with this report.
Key Figures
Cash, cash equivalents and investments: $2,741.2M
Net proceeds from equity offering: $601.8M
Gross equity offering proceeds: $632.5M
+5 more
8 metrics
Cash, cash equivalents and investments
$2,741.2M
As of March 31, 2026
Net proceeds from equity offering
$601.8M
February 2026 equity financing
Gross equity offering proceeds
$632.5M
12,650,000 shares at $50.00 per share
R&D expenses
$312.8M
Three months ended March 31, 2026
Net loss
$320.6M
Three months ended March 31, 2026
Net loss per share
$2.30
Basic and diluted, Q1 2026
Cash position prior period
$2,442.6M
Cash, cash equivalents and investments as of December 31, 2025
Total stockholders' equity
$2,996.0M
As of March 31, 2026
Key Terms
pivotal, noninferiority trial, Biologics Application License (BLA), opsonophagocytic activity (OPA), immunoglobulin G (IgG), +2 more
6 terms
pivotal, noninferiority trial medical
"the OPUS-1 Phase 3 pivotal, noninferiority trial with 4,049 participants dosed"
Biologics Application License (BLA) regulatory
"maintaining the timeline for our planned Biologics Application License (BLA) submission"
A Biologics License Application (BLA) is the formal submission a drug maker files with a national regulator (in the U.S., the FDA) asking for permission to sell a biologic — a medicine made from living cells. It bundles clinical trial results, safety data and manufacturing details so the regulator can decide whether the product is safe and effective; approval is a market gateway that can unlock significant revenue or, if delayed or denied, pose a major commercial setback, much like receiving or being denied a operating permit for a large factory.
opsonophagocytic activity (OPA) medical
"VAX-31 demonstrated robust opsonophagocytic activity (OPA) and immunoglobulin G (IgG) immune responses"
Opsonophagocytic activity (OPA) measures how well antibodies in blood tag pathogens so immune cells can engulf and destroy them; think of it as testing whether the body’s ‘paint’ makes bacteria or viruses visible to the immune system’s ‘cleanup crew.’ For investors, OPA is a functional test often used to show a vaccine or antibody product actually neutralizes targets, influencing clinical value, regulatory decisions, and commercial potential.
immunoglobulin G (IgG) medical
"opsonophagocytic activity (OPA) and immunoglobulin G (IgG) immune responses"
Immunoglobulin G (IgG) is the most abundant antibody the body makes to spot and neutralize germs and to remember past infections; think of it as the immune system’s long-term security cameras and memory cards. For investors, IgG matters because tests that measure IgG, medicines built from or mimicking IgG, and engineered IgG therapies are common products in diagnostics, vaccines and biopharma pipelines, influencing clinical results, regulatory decisions and potential revenues.
stock-based compensation expense financial
"Amounts include stock-based compensation expense as follows"
Stock-based compensation expense is the value that a company records when it gives employees or executives shares or options to buy shares as part of their pay. It matters because it shows the true cost of paying employees this way, which can affect the company's profits and how investors see its financial health.
cell-free protein synthesis platform technical
"XpressCF®, its cell-free protein synthesis platform exclusively licensed from Sutro Biopharma, Inc."
Earnings Snapshot
R&D expenses: $312.8M
Q1 2026
R&D expenses
$312.8M
G&A expenses
$33.1M
Net loss
$320.6M
Net loss per share
$2.30
Cash, cash equivalents and investments
$2,741.2M
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): May 6, 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 May 6, 2026, Vaxcyte, Inc. issued a press release announcing its financial results for the quarter ended March 31, 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 May 6, 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: | May 6, 2026 | By: | /s/ Andrew Guggenhime | ||||||||
| Andrew Guggenhime President and Chief Financial Officer | |||||||||||
Exhibit 99.1
Vaxcyte Reports First Quarter 2026 Financial Results and Provides Business Update
Enrollment Now Completed for OPUS-1, OPUS-2 and OPUS-3 Phase 3 Trials Evaluating VAX-31 for the Prevention of Invasive Pneumococcal Disease and Pneumonia in Adults
Topline Safety, Tolerability and Immunogenicity Data from OPUS-1 Expected in Fourth Quarter of 2026; OPUS-2 and OPUS-3 Results Expected in First Half of 2027
Enrollment Completed for VAX-31 Infant Phase 2 Dose-Finding Study; Topline Safety, Tolerability and Immunogenicity Data from Primary Immunization Series and Booster Dose Expected Either Sequentially or Together by End of First Half of 2027
Company Expects to Initiate Phase 1 Adult Clinical Study for VAX-A1, a Vaccine Candidate to Prevent Disease Caused by Group A Strep, in Mid-2026
Approximately $2.7 Billion in Cash, Cash Equivalents and Investments as of March 31, 2026, Including $601.8 Million in Net Proceeds from February 2026 Equity Offering
SAN CARLOS, Calif., May 6, 2026 – Vaxcyte, Inc. (Nasdaq: PCVX), a clinical-stage vaccine innovation company, today announced financial results for the first quarter ended March 31, 2026, and provided a business update.
"With the recent completion of OPUS-3 enrollment, our OPUS-1, OPUS-2 and OPUS-3 adult Phase 3 trials are now fully enrolled, and we remain on track to deliver data from these studies beginning with the expected OPUS-1 topline readout in the fourth quarter," said Grant Pickering, Chief Executive Officer and Co-Founder of Vaxcyte. "Our OPUS Phase 3 program was designed to establish not only a best-in-class pneumococcal conjugate vaccine (PCV), but also a new standard by which other pneumococcal vaccines will be judged. Based on the unprecedented results from our VAX-31 Phase 1/2 study in adults and the advantages of our carrier-sparing platform, we designed the OPUS-1 noninferiority trial as a head-to-head comparison against both Prevnar 20® (PCV20) and Capvaxive® (PCV21) with the potential to deliver a 14-34% increase in coverage against invasive pneumococcal disease (IPD) and a 19-31% increase in coverage against pneumococcal pneumonia relative to the current standard-of-care PCVs in U.S. adults. Following the anticipated OPUS-1 data in the fourth quarter, we expect to announce the results of the OPUS-2 and OPUS-3 Phase 3 trials in the first half of 2027, maintaining the timeline for our planned Biologics Application License (BLA) submission and potential U.S. commercial launch."
"In the first quarter of 2026, we completed an equity financing that further strengthened our balance sheet and extended our cash runway," said Andrew Guggenhime, President and Chief Financial Officer of Vaxcyte. "With $2.7 billion in cash, cash equivalents and investments as of March 31, 2026, we are well positioned to execute on our planned clinical, manufacturing and commercial readiness milestones for our PCV development programs and support the Company’s
next phase of growth. This includes advancing VAX-A1, a prophylactic vaccine candidate designed to prevent disease caused by Group A Strep, into the clinic in mid-2026."
Key First Quarter and Recent Highlights
PCV Franchise Adult Indication:
Advanced Comprehensive VAX-31 Phase 3 Adult Clinical Program to Support Planned BLA Submission, with Enrollment Completed for Three OPUS Trials: 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 U.S. Food and Drug Administration (FDA), are designed to generate a broad and robust safety, tolerability and immunogenicity dataset. In addition, the Company is also planning a manufacturing consistency study (e.g., a lot-to-lot study) as the final Phase 3 study.
•In March 2026, the Company announced the completion of enrollment in the OPUS-1 Phase 3 pivotal, noninferiority trial with 4,049 participants dosed and the OPUS-2 Phase 3 trial evaluating VAX-31 concomitantly administered with a seasonal influenza vaccine with 1,390 participants dosed. OPUS-1 is evaluating the safety, tolerability and immune responses of VAX-31 in healthy, pneumococcal-naïve1 adults aged 50 and older through direct, head-to-head comparisons with both PVC20 and PCV21, 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 a separate cohort of adults aged 18-49. OPUS-2 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 pneumococcal-naïve, healthy 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 Company recently completed enrollment in the OPUS-3 trial, a Phase 3 descriptive study evaluating the safety, tolerability and immunogenicity of VAX-31 in adults who have previously received pneumococcal vaccination, including whether VAX-31 can expand the breadth of protection and boost responses to the serotypes included in the lower-valency pneumococcal vaccines that participants previously received. In the study, 752 adults aged 50 years and older who have previously received lower-valency pneumococcal vaccines were dosed.
Positive VAX-31 Phase 1/2 Adult Data Published in The Lancet Infectious Diseases: In March 2026, the Company announced the publication of results from the positive VAX-31 adult Phase 1/2 clinical study in the journal The Lancet Infectious Diseases. The study results showed that VAX-31 at all doses studied was observed to be well tolerated and demonstrated a safety profile similar to PCV20 through the full six-month evaluation period. At all doses studied, VAX-31 demonstrated robust opsonophagocytic activity (OPA) and immunoglobulin G (IgG) immune responses, with high geometric mean concentrations (GMCs) across all 31 serotypes. The VAX-31 High Dose, which is currently being evaluated in the VAX-31 adult OPUS Phase 3 program, met or exceeded the OPA
1 Pneumococcal-naïve is defined as having no known prior history of IPD or pneumococcal pneumonia, or receipt of any licensed or investigational pneumococcal vaccine.
response noninferiority criteria2 for all 20 serotypes common with PCV20 and met the superiority criteria3 for the 11 incremental serotypes unique to VAX-31 and not in PCV20. The VAX-31 High Dose average OPA immune responses were greater for 18 of 20 serotypes compared to PCV20 (geometric mean ratio (GMR) greater than 1.0), with seven of these serotypes achieving statistically higher immune responses4 compared to PCV20.
PCV Franchise Infant Indication:
Completed Enrollment in VAX-31 Infant Phase 2 Study: In January 2026, the Company announced the completion of enrollment in the VAX-31 infant Phase 2 dose-finding study, with 900 healthy infants dosed. Participants have received at least their second dose in the primary immunization series. VAX-31 is designed to substantially expand coverage in the pediatric population by adding 11 incremental serotypes over and above today's standard-of-care, PCV20. VAX-31 has the potential to increase protection against IPD from approximately 69% to approximately 92% of disease circulating in children under five years of age in the U.S. and increase protection against acute otitis media from approximately 61% to approximately 96% in U.S. children five years of age or under.
Early-Stage Pipeline:
Advancing VAX-A1, a Potential Best-in-Class Vaccine Candidate Designed to Provide Universal Protection Against Disease Caused by Group A Strep, into the Clinic: In mid-2026, the Company plans to initiate a Phase 1 adult study for its most advanced preclinical program, VAX-A1, a prophylactic vaccine candidate designed to prevent disease caused by Group A Strep (Streptococcus pyogenes), with the primary objective of assessing safety and tolerability, along with a secondary objective of evaluating initial immunogenicity data, to support potential further advancement. This approach is designed to generate high-quality initial safety data and provide a foundation for evaluating next steps in the program's development. The Company intends to conduct this study in Australia, where Group A Strep has been problematic and there are experienced investigator networks with a high degree of expertise in the field. Group A Strep remains a major global cause of morbidity and mortality in adults and children and is a leading driver of antibiotic use, underscoring the significant public health burden.
Equity Financing:
Completed Underwritten Public Offering, Further Strengthening Balance Sheet: In February 2026, Vaxcyte completed an underwritten public offering of 12,650,000 shares of its common stock, which included the full exercise of the underwriters’ option to purchase an additional 1,650,000 shares, at a public offering price of $50.00 per share. The aggregate gross proceeds to Vaxcyte from this offering were $632.5 Million, before deducting underwriting discounts and commissions and other offering expenses payable by Vaxcyte.
2 Lower bound of the 2-sided 95% confidence interval of the OPA geometric mean ratio is greater than 0.5.
3 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 geometric mean ratio is greater than 2.0.
4 Lower bound of the 2-sided 95% confidence interval of the OPA geometric mean ratio is greater than 1.0.
Commercial Manufacturing & Supply Chain:
Progressed Manufacturing and Supply Chain Capabilities to Support Commercial Launch: In collaboration with Lonza, Vaxcyte completed construction of a dedicated, large-scale manufacturing facility designed to support potential global commercial manufacturing of its PCV candidates for all indications.
Established North Carolina Presence Including Buildout of Custom PCV Fill-Finish Line: In January 2026, Vaxcyte announced the establishment of a dedicated local North Carolina presence, comprising full-time employees focused on chemistry, manufacturing and controls (CMC) activities as part of its commitment to expand U.S.-based fill-finish manufacturing capacity for its PCVs in North Carolina. As the Company advances its long-term domestic manufacturing strategy, it is recruiting experienced scientific and manufacturing professionals in one of the country’s most established vaccine-development hubs. In parallel, the buildout of the custom PCV fill-finish line at the North Carolina facility is well underway.
Anticipated Program Milestones
Vaxcyte is advancing the clinical development of its pipeline programs with several key milestones anticipated:
VAX-31 Adult Indication
•Announce topline safety, tolerability and immunogenicity data from the OPUS-1 Phase 3 pivotal, noninferiority trial in the fourth quarter of 2026.
•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
•Initiate Phase 1 adult clinical study in mid-2026, with the primary objective of assessing safety and tolerability.
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.
•BofA Securities 2026 Health Care Conference, May 12-14: Fireside chat will take place live on Tuesday, May 12, at 4:40 p.m. ET / 1:40 p.m. PT.
•Jefferies Global Healthcare Conference, June 2-4: Fireside chat will take place live on Wednesday, June 3, at 4:20 p.m. ET / 1:20 p.m. PT.
First Quarter 2026 Financial Results
•Cash Position: Cash, cash equivalents and investments were $2,741.2 million as of March 31, 2026, compared to $2,442.6 million as of December 31, 2025.
•Research & Development (R&D) Expenses: R&D expenses were $312.8 million for the three months ended March 31, 2026 as compared to $148.1 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 an increase in manufacturing activities to support the potential future commercial launches, clinical trial expenses primarily related to the initiation and enrollment of the VAX-31 OPUS Phase 3 trials and higher personnel expenses related to the growth in the number of R&D employees.
•General & Administrative (G&A) Expenses: G&A expenses were $33.1 million for the three months ended March 31, 2026 as compared to $32.7 million for the same period in 2025.
•Net Loss: For the three months ended March 31, 2026, net loss was $320.6 million, compared to $140.7 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, is designed to cover more serotypes than any infant 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.
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 accelerate its ability to develop high-fidelity vaccines with enhanced immunological benefits. Vaxcyte’s pipeline also includes VAX-A1, a prophylactic vaccine candidate designed to prevent Group A Strep infections, and 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 PCVs and
improve upon the standard-of-care; the design, timing of initiation, progress and expected results of Vaxcyte's clinical trials and regulatory plans; 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,” “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 May 6, 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. Readers should not rely upon the information in this press release as current or accurate after its publication date.
# # #
Contacts:
Patrick Ryan, Executive Director, Corporate Affairs
Vaxcyte, Inc.
415-606-5135
media@vaxcyte.com
Jeff Macdonald, Executive Director, Investor Relations
Vaxcyte, Inc.
917-371-094
investors@vaxcyte.com
Vaxcyte, Inc.
Condensed Consolidated Statements of Operations
(in thousands, except share and per share amounts)
Three Months Ended March 31, | |||||||||||
2026 | 2025 | ||||||||||
Operating expenses: | |||||||||||
Research and development (1) | $ | 312,779 | $ | 148,134 | |||||||
General and administrative (1) | 33,071 | 32,659 | |||||||||
Total operating expenses | 345,850 | 180,793 | |||||||||
Loss from operations | (345,850) | (180,793) | |||||||||
Other income, net: | |||||||||||
Interest income | 26,610 | 32,935 | |||||||||
Other income (expense) | (1,382) | 7,140 | |||||||||
Total other income, net | 25,228 | 40,075 | |||||||||
Net loss | $ | (320,622) | $ | (140,718) | |||||||
Net loss per share, basic and diluted | $ | (2.30) | $ | (1.04) | |||||||
Weighted-average shares outstanding, basic and diluted | 139,506,680 | 135,690,949 | |||||||||
___________________________________________
(1)Amounts include stock-based compensation expense as follows:
Research and development | $ | 20,678 | $ | 15,925 | |||||||
General and administrative | 17,286 | 14,690 | |||||||||
Total stock-based compensation expense | $ | 37,964 | $ | 30,615 | |||||||
Vaxcyte, Inc.
Summary Consolidated Balance Sheet Data
(in thousands)
March 31, 2026 | December 31, 2025 | ||||||||||
Cash, cash equivalents and investments | $ | 2,741,195 | $ | 2,442,623 | |||||||
Total assets | 3,348,308 | 3,002,717 | |||||||||
Total stockholders' equity | 2,996,014 | 2,685,510 | |||||||||
FAQ
What were Vaxcyte (PCVX) key clinical milestones reported for VAX-31 in Q1 2026?
Vaxcyte reported that all three adult Phase 3 OPUS trials of VAX-31 are fully enrolled, with 6,191 adults dosed. Topline OPUS-1 safety, tolerability and immunogenicity data are expected in the fourth quarter of 2026, and OPUS-2 and OPUS-3 results in the first half of 2027.
How strong is Vaxcyte (PCVX) cash position after its February 2026 equity offering?
Vaxcyte ended March 31, 2026 with $2.74 billion in cash, cash equivalents and investments, including $601.8 million in net proceeds from a February 2026 equity offering. The underwritten deal sold 12,650,000 shares at $50.00 per share, yielding $632.5 million in gross proceeds.
What were Vaxcyte (PCVX) first-quarter 2026 R&D and net loss figures?
For the three months ended March 31, 2026, Vaxcyte recorded research and development expenses of $312.8 million and general and administrative expenses of $33.1 million. Net loss was $320.6 million, or $2.30 per basic and diluted share, reflecting intensive late-stage development spending.
What progress did Vaxcyte (PCVX) report on its VAX-31 infant program?
Vaxcyte completed enrollment of its VAX-31 infant Phase 2 dose-finding study, dosing 900 healthy infants. Topline safety, tolerability and immunogenicity data from the three-dose primary series and booster are expected either sequentially or together by the end of the first half of 2027.
When will Vaxcyte (PCVX) start clinical testing of its VAX-A1 Group A Strep vaccine?
Vaxcyte plans to initiate a Phase 1 adult clinical study of VAX-A1, its Group A Strep vaccine candidate, in mid-2026. The trial, to be conducted in Australia, will primarily assess safety and tolerability, with secondary evaluation of initial immunogenicity to guide potential further development.
What manufacturing and supply chain steps has Vaxcyte (PCVX) taken toward commercialization?
Vaxcyte and Lonza have completed construction of a dedicated large-scale facility to support global commercial manufacturing of its pneumococcal conjugate vaccine candidates. The company also established a North Carolina presence and is building a custom PCV fill-finish line, expanding U.S.-based manufacturing capacity.