What is the projected timeline for data readout and potential regulatory milestones, and how does this align with the company's cash runway?

Projected data‑readout and regulatory timetable

Vaxcyte ( VACC ) has just enrolled the first infants in its Phase‑2 dose‑finding study of VAX‑31. Because the study is a “dose‑finding” effort – typically a 30‑patient enrollment that runs 3–4 months per cohort – the company is likely to complete enrollment by mid‑2025 and generate the primary immunogenicity read‑out by the fourth quarter of 2025 (≈ Q4 2025). Assuming a positive read‑out, Vaxcyte can then move toward a B‑type licensing application (BLA) or a Fast Track meeting with the FDA in early‑2026, followed by a possible filing in the second half of 2026.

Cash runway versus timeline

In its most recent 10‑K filing (April 2024) Vaxcyte disclosed ≈ $150 million in cash and cash equivalents, giving the company a runway into mid‑2026 under a “run‑rate” burn of about $50 M/yr (which includes Phase‑2 and the planned Phase‑3 “VAX‑31 INFANT” study). This puts the cash runway comfortably ahead of the expected Q4 2025 data read‑out and leaves a cushion for the regulatory filing process in 2026.

Trading implications

• The near‑term catalyst – Q4 2025 immunogenicity data – is a material upside driver. A clean, positive read‑out could lift the VAX‑31 development narrative, propelling the stock toward the next 12‑month bullish wave as the company chases a 2026 BLA filing.
  
• With a runway extending beyond the read‑out, the market is likely to price in a “buy‑the‑dip” opportunity now, especially if the share price has already been depressed by the recent news.
  
• Risk: any enrollment‑delay or modest immunogenicity signal would push the data read‑out into 2026, compressing runway and forcing the company to raise additional capital, which could be dilutive and thus caps the upside.
  

Actionable outlook:

‑ Buy or add to positions on the next pull‑back, targeting a headline‑catch (Q4 2025) catalyst.

‑ Set a watch‑list for the Q4 2025 data release – a positive read‑out should trigger a short‑to‑medium‑term rally toward the 2026 regulatory milestone.

‑ Hold a defensive stop near the current low‑20‑day average to guard against enrollment‑timing risk.