Zentalis Pharmaceuticals, Inc. 8-K

What Happened
Zentalis Pharmaceuticals (ZNTL) filed an 8-K (Regulation FD disclosure) on January 9, 2026, furnishing a corporate presentation and announcing a corporate update delivered January 6, 2026. The company said it completed enrollment in DENALI Part 2a of its Phase 2 trial (NCT05128825), confirmed FDA alignment on the design of the ASPENOVA Phase 3 confirmatory trial, and outlined key 2026 milestones for its lead asset, azenosertib. Zentalis reported cash, cash equivalents and marketable securities of $280.7 million as of September 30, 2025, and said this is expected to provide runway into late 2027.

Key Details

• DENALI Part 2a enrollment completed; Part 2a targeted ~30 patients per dose cohort (400 mg QD 5:2 and 300 mg QD 5:2) to confirm dose of interest.
• FDA alignment reached on ASPENOVA Phase 3 trial comparing azenosertib to standard-of-care chemotherapy in Cyclin E1–positive platinum-resistant ovarian cancer (PROC).
• 2026 timing goals: DENALI Part 2a dose confirmation in H1 2026; ASPENOVA Phase 3 initiation in H1 2026 (to run concurrently with DENALI Part 2); DENALI Part 2 topline readout expected by year-end 2026.
• Biomarker note: Cyclin E1 protein overexpression observed as a predictive biomarker; Zentalis estimates ~50% of PROC patients overexpress Cyclin E1 based on its IHC cutoff.
• Cash position: $280.7 million (Sept 30, 2025) — company expects runway into late 2027, beyond the anticipated DENALI Part 2 topline readout.

Why It Matters
These updates focus on clinical and regulatory milestones that can materially affect Zentalis’s development pathway and valuation. Completion of DENALI Part 2a enrollment, FDA alignment on a Phase 3 design, and clear 2026 timing create nearer-term catalysts (dose confirmation, trial initiation, and topline readout) that investors track closely. The reported cash balance and stated runway into late 2027 provide a view of near-term funding sufficiency, though the filing also reiterates standard forward-looking risks and that outcomes are not guaranteed.