Key Highlights

  • Net loss per share was USD 1.99 against an estimate of USD -2.11, on a USD 297.1 million net loss.
  • Research and development expense was USD 270.3 million, against USD 209.9 million in the prior-year quarter.
  • Concurrent October offerings of stock, pre-funded warrants and convertible notes brought gross proceeds of approximately USD 1.15 billion.
  • Cash, cash equivalents and investments totaled USD 2.3 billion at September 30, with an accumulated Deficit of USD 3.1 billion.

Vaxcyte (NASDAQ:PCVX), a clinical-stage Vaccine company with no approved products and no product revenue, based its third quarter around the October announcement of pivotal adult Phase 3 results for VAX-31, its 31-valent pneumococcal conjugate vaccine candidate. Net loss per share was USD 1.99 against an estimate of USD -2.11, and the net loss was USD 297.1 million against USD 212.8 million a year earlier.

VAX-31, VAX-24 and the Pipeline

Management said the OPUS-1 trial enrolled 3,572 adults aged 50 and older, plus 475 adults aged 18 to 49, and compared VAX-31 head to head with PCV20 and PCV21. The company reported that VAX-31 met all prespecified primary endpoints. All 28 serotypes shared with PCV20 or PCV21 met the noninferiority criteria, and the three serotypes unique to VAX-31 plus cross-reactive serotype 20B met the superiority criterion. Against PCV21 specifically, serotypes 3 and 12F did not meet the primary noninferiority threshold but met a historical one. The FDA has granted Breakthrough Therapy Designation for VAX-31 in adults.

Two further Phase 3 studies are underway: OPUS-2, alongside or after a seasonal influenza vaccine, and OPUS-3, in adults with prior pneumococcal vaccination. Enrollment is complete in both, and management stated that data from each is planned for the first half of 2027. A Manufacturing consistency study is planned as the final Phase 3 study needed for a Biologics License Application.

In infants, the VAX-31 Phase 2 dose-finding study completed enrollment in January 2026 with 900 participants, and management stated that topline data is planned by the end of the first half of 2027.

Quarterly Results and Spending

Operating expenses were USD 308.3 million, against USD 242.4 million a year earlier. Research and Development was USD 270.3 million, with product manufacturing costs of USD 130.9 million and clinical trial expenses of USD 38.4 million, against USD 110.7 million and USD 19.7 million. Management tied the manufacturing increase to activities supporting potential future commercial launches and the clinical trial increase to the OPUS-1, OPUS-2 and OPUS-3 studies.

Interest income was USD 23.2 million against USD 29.3 million. For nine months, the net loss was USD 902.0 million, or USD 6.25 per share, against USD 520.1 million, or USD 3.83 per share.

Financing, Cash and Manufacturing

Cash and cash equivalents were USD 0.1 billion and investments were USD 2.1 billion at September 30. Nine-month operating cash use was USD 737.2 million against USD 430.7 million. A February 2026 offering of 12,650,000 shares at USD 50.00 raised net proceeds of USD 601.8 million.

After the OPUS-1 results, it completed concurrent offerings in October 2026 of 8,584,375 shares at USD 64.00, pre-funded warrants for 400,000 shares, and USD 575 million of 1.50% convertible senior notes due 2032, with an initial conversion price of approximately USD 89.60. Gross proceeds were approximately USD 1.15 billion. Management said cash and investments are sufficient to fund operations through at least 12 months from the Quarterly Report filing date, and that substantial additional Capital is still needed.

The dedicated manufacturing suite at Lonza in Visp, Switzerland was transferred to Lonza's operations team in August 2026.

Signposts for the Next Quarter

A net loss of USD 297.1 million sits alongside cash and investments of USD 2.3 billion, nine-month operating cash use of USD 737.2 million and October gross proceeds of approximately USD 1.15 billion.

Management named a short list of items: OPUS-2 and OPUS-3 data in the first half of 2027, infant Phase 2 topline data by the end of that half, a lot-to-lot manufacturing study ahead of a Biologics License Application, and a Phase 3 infant program with VAX-24 or VAX-31 pending the infant readout.