Vaxcyte Reports Third Quarter 2026 Financial Results and Provides Business Update
Vaxcyte, Inc. (PCVX) filed an SEC Form 8-K — Results of Operations and Financial Condition. 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 P
How this was made
The 30-second read
Why it matters
The announcement combines financial results with pivotal trial success, a rare dual catalyst.
Market read
First‑report of Phase 3 success and a $1.1B capital raise provide fresh material for traders.
What to watch
Potential competition from existing PCVs and the need for FDA approval timelines.
Vaxcyte reported positive topline OPUS-1 Phase 3 data for VAX-31, increased third-quarter R&D spending and net loss, and completed October offerings that generated approximately $1.1 billion in net proceeds.
OPUS-1 met all prespecified co-primary immunogenicity endpoints and the company added approximately $1.1 billion in net proceeds, but quarterly net loss widened to $297.1 million as R&D expense increased to $270.3 million.
Key metrics
shortened, hover for the filing’s print| Metric | Value | q/q | y/y |
|---|---|---|---|
| Research and development expenses, three months ended September 30, 2026GAAP | $270.3M | – | – |
| General and administrative expenses, three months ended September 30, 2026GAAP | $37.95M | – | – |
| Total operating expenses, three months ended September 30, 2026GAAP | $308.3M | – | – |
| Loss from operations, three months ended September 30, 2026GAAP | −$308.3M | – | – |
| Interest income, three months ended September 30, 2026GAAP | $23.19M | – | – |
| Other (expense) income, three months ended September 30, 2026GAAP | −$11.98M | – | – |
| Total other income, net, three months ended September 30, 2026GAAP | $11.21M | – | – |
| Net loss, three months ended September 30, 2026GAAP | −$297.1M | – | – |
| Net loss per share, basic and diluted, three months ended September 30, 2026GAAP | $ (1.99) | – | – |
| Weighted-average shares outstanding, basic and diluted, three months ended September 30, 2026GAAP | 148,908,274 | – | – |
| Research and development expenses, nine months ended September 30, 2026GAAP | $851.0M | – | – |
| General and administrative expenses, nine months ended September 30, 2026GAAP | $105.9M | – | – |
| Total operating expenses, nine months ended September 30, 2026GAAP | $956.9M | – | – |
| Loss from operations, nine months ended September 30, 2026GAAP | −$956.9M | – | – |
| Interest income, nine months ended September 30, 2026GAAP | $75.55M | – | – |
| Other (expense) income, nine months ended September 30, 2026GAAP | −$20.64M | – | – |
| Total other income, net, nine months ended September 30, 2026GAAP | $54.91M | – | – |
| Net loss, nine months ended September 30, 2026GAAP | −$902.0M | – | – |
| Net loss per share, basic and diluted, nine months ended September 30, 2026GAAP | $ (6.25) | – | – |
| Weighted-average shares outstanding, basic and diluted, nine months ended September 30, 2026GAAP | 144,337,459 | – | – |
| Research and development stock-based compensation expense, three months ended September 30, 2026GAAP | $24.07M | – | – |
| General and administrative stock-based compensation expense, three months ended September 30, 2026GAAP | $17.03M | – | – |
| Total stock-based compensation expense, three months ended September 30, 2026GAAP | $41.1M | – | – |
| Research and development stock-based compensation expense, nine months ended September 30, 2026GAAP | $66.90M | – | – |
| General and administrative stock-based compensation expense, nine months ended September 30, 2026GAAP | $53.41M | – | – |
| Total stock-based compensation expense, nine months ended September 30, 2026GAAP | $120.3M | – | – |
| Cash, cash equivalents and investments, September 30, 2026GAAP | $2.26B | – | – |
| Total assets, September 30, 2026GAAP | 2.99B | – | – |
| Total stockholders' equity, September 30, 2026GAAP | 2.49B | – | – |
First half of 2027, end of the first half of 2027, second half of 2027, and first half of 2028 outlook
- NoteAnnounce safety, tolerability and immunogenicity data from the OPUS-2 and OPUS-3 Phase 3 trials in the first half of 2027.
- NoteAnnounce 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.
- NoteAnnounce topline data from the VAX-A1 Phase 1 study in adults in the second half of 2027.
- NotePlanned Biologics License Application submission for VAX-31 in the first half of 2028.
What drove it
- R&D expense increased primarily because of higher development and product manufacturing costs associated with PCV programs, including manufacturing activities supporting potential future commercial launches and clinical trial expenses primarily related to the VAX-31 OPUS Phase 3 trials.
- R&D expense also reflected higher personnel expenses related to growth in the number of R&D employees.
- G&A expense increased primarily because of higher personnel expenses related to growth in the number of G&A employees and professional and consulting services.
- VAX-31 met all prespecified co-primary immunogenicity endpoints in adults 50 and older in OPUS-1.
- VAX-31 met the primary immunobridging noninferiority criterion for all 32 serotype OPA GMR comparisons in adults aged 18-49 compared to adults aged 50-64.
- VAX-A1 advanced to Stage 2 after an independent Data Safety Monitoring Board review of Stage 1 safety and tolerability data.
Concerns
- The company reported a net loss of $297.1 million for the three months ended September 30, 2026, compared to $212.8 million for the same period in 2025.
- In individual comparator-specific analyses against PCV21, serotypes 3 and 12F did not meet the LBCI >0.667 noninferiority criterion, although they met the historical LBCI >0.5 threshold.
- The company expects the comparison of VAX-31 to PCV21 to be a particular focus of FDA review.
- The September 30, 2026 cash balance does not include the approximately $1.1 billion in net proceeds from the October 2026 offerings.
What to watch
- OPUS-2 and OPUS-3 Phase 3 safety, tolerability and immunogenicity data in the first half of 2027.
- VAX-31 infant Phase 2 primary-series and booster-dose topline data by the end of the first half of 2027.
- VAX-A1 Phase 1 adult topline data in the second half of 2027.
- The planned manufacturing consistency study, described as the final Phase 3 study to enable VAX-31 BLA submission.
- Planned VAX-31 BLA submission in the first half of 2028.
Balance sheet and cash flow
- 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.
- In October 2026, concurrent underwritten public offerings 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.
- Aggregate net proceeds were approximately $1.1 billion after underwriting discounts and commissions and estimated offering expenses.
- The convertible senior notes bear interest at 1.50% per annum and mature in October 2032.
- Pro forma cash, cash equivalents and investments were approximately $3.4 billion as of September 30, 2026, including approximately $1.1 billion in net proceeds from the October 2026 offerings.
Analysis
Vaxcyte's third-quarter update was defined by positive OPUS-1 topline data for VAX-31 rather than commercial activity. In adults aged 50 and older, VAX-31 met all prespecified co-primary immunogenicity endpoints. The company also reported that the primary immunobridging endpoint met the noninferiority criterion for all 32 serotype OPA GMR comparisons in adults aged 18-49 versus adults aged 50-64. VAX-31 was well tolerated, with a safety profile similar to PCV20 and PCV21, no serious adverse events considered related to study vaccines, and no study discontinuations due to adverse events.
The comparator detail remains important for the regulatory path. VAX-31 met the individual noninferiority criterion for 20 of 20 serotypes shared with PCV20 and 17 of 19 shared with PCV21. Serotypes 3 and 12F did not meet the LBCI >0.667 criterion against PCV21, though both met the historical LBCI >0.5 threshold. Management stated that the VAX-31 comparison to PCV21 is expected to be a particular focus of FDA review. OPUS-2 and OPUS-3 are fully enrolled and expected to report in the first half of 2027, while a manufacturing consistency study is planned as the final Phase 3 study to enable a BLA submission in the first half of 2028.
The financial statements show rising development investment. R&D expense was $270.3 million for the three months ended September 30, 2026, compared with $209.9 million in the prior-year period, driven by PCV development and product manufacturing, OPUS Phase 3 clinical trial expense, and higher R&D personnel expense. G&A expense was $37.9 million versus $32.4 million. The resulting net loss was $297.1 million, compared with $212.8 million, while basic and diluted net loss per share was $1.99 versus $1.56.
Liquidity was reinforced after period end. Cash, cash equivalents and investments were $2,264.4 million at September 30, 2026, and the October equity and convertible-note offerings added approximately $1.1 billion in net proceeds, producing approximately $3.4 billion of pro forma cash, cash equivalents and investments. The financing included $575 million of convertible senior notes bearing interest at 1.50% per annum and maturing in October 2032. The central upcoming operating milestones are OPUS-2 and OPUS-3 data in the first half of 2027, infant Phase 2 data by the end of that half-year, and VAX-A1 Phase 1 data in the second half of 2027.
Management, verbatim
The positive topline results from OPUS-1 represent a significant milestone for Vaxcyte and our broad-spectrum pneumococcal conjugate vaccine (PCV) franchise.
Grant Pickering, Chief Executive Officer and Co-Founder of Vaxcyte
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.
Grant Pickering, Chief Executive Officer and Co-Founder 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.
Andrew Guggenhime, President and Chief Financial Officer of Vaxcyte
Not in the filing
stated, not guessed- Revenue for the three months ended September 30, 2026 and 2025 was not reported.
- Revenue for the nine months ended September 30, 2026 and 2025 was not reported.
- Segment revenue and segment profitability were not reported.
- Gross profit, gross margin, operating margin, and net margin were not reported.
- Non-GAAP financial measures, including non-GAAP net income or loss and non-GAAP EPS, were not reported.
- Operating cash flow, capital expenditures, and free cash flow were not reported.
- A cash-flow statement was not reported.
- Financial revenue, gross margin, operating expense, or tax-rate guidance was not reported.
- Dividends and share repurchases were not reported.
- Total debt as of September 30, 2026 was not reported.
- Prior-quarter operating-results comparisons were not reported.
- Percentage year-over-year and sequential changes for reported financial statement line items were not printed.
Written by an AI language model from the company’s SEC earnings filing (Form 8-K Item 2.02, or Form 6-K for a foreign private issuer). Every figure is checked against the filing text, and a metric the filing does not print, or whose value, prior period and change do not add up, is dropped from the metrics. The model can still misread a table, in the metrics or in the text, so check a number in the filing before you rely on it. Consensus estimates, price targets and share-price reactions are not shown because they are not in the filing. AI-generated research, not investment advice.
Background
The filing is a standard SEC Form 8‑K reporting quarterly results and clinical updates.
Ticker impact
Vaxcyte disclosed positive Phase 3 topline data for VAX-31 and announced $1.1B raised from equity and convertible notes.
upward pressure as market prices in the favorable trial results and capital raise.
First disclosure of pivotal trial success and sizable financing typically drive short-term price gains.
Market effects
Strengthens the broader vaccine and biotech sector outlook, especially for pneumococcal candidates.
May lift US biotech indices and related exchange-traded funds.
Positive data could influence global vaccine pipelines and partnership interest.
Counterpoint
If regulatory scrutiny intensifies or comparative data to PCV20/21 falters, the rally could be limited.
Key entities
- companyVaxcyte, Inc.
Clinical‑stage vaccine developer.
- executiveGrant Pickering
CEO of Vaxcyte.
