ZeZentalis Pharma | 8-K: FY2025 Q3 Revenue: USD 0

Revenue: As of FY2025 Q3, the actual value is USD 0.

EPS: As of FY2025 Q3, the actual value is USD -0.37, beating the estimate of USD -0.48.

Cash, Cash Equivalents and Marketable Securities

• As of September 30, 2025, Zentalis Pharmaceuticals, Inc. had cash, cash equivalents, and marketable securities totaling $280.7 million. The company believes this will be sufficient to fund its operating expenses into late 2027.

Research and Development Expenses

• Research and development (R&D) expenses for the three months ended September 30, 2025, were $23.0 million, compared to $36.8 million for the same period in 2024. This represents a decrease of $13.8 million, primarily due to reductions in personnel expenses, lab services, clinical expenses, and other overhead costs.

General and Administrative Expenses

• General and administrative expenses for the three months ended September 30, 2025, were $10.8 million, compared to $14.6 million for the same period in 2024. This decrease of $3.8 million was mainly due to a reduction in personnel expenses.

Operating Expenses

• Total operating expenses for the three months ended September 30, 2025, were $33.7 million, compared to $51.4 million for the same period in 2024.

Net Loss

• Net loss for the three months ended September 30, 2025, was $26.7 million, compared to $40.2 million for the same period in 2024.

Unique Metrics

• Azenosertib demonstrated a >30% objective response rate (ORR) and a median duration of response (mDOR) of approximately 6 months in Cyclin E1-positive platinum-resistant ovarian cancer (PROC) patients.
• Interim clinical data showed clinically meaningful results and a manageable safety profile across multiple azenosertib monotherapy studies, with over 200 PROC patients treated at 300mg and 400mg QD 5:2.

Outlook / Guidance

• Zentalis Pharmaceuticals, Inc. anticipates initiating a Phase 3 confirmatory trial following FDA feedback in 2026, with topline data from registration-intent DENALI Part 2 expected by the end of 2026. There is potential for FDA accelerated approval in Cyclin E1-positive PROC patients, subject to supportive data and FDA feedback and approval.