Zentalis Pharmaceuticals — Third Quarter 2026 Earnings Summary

Financial Performance:

• Total operating expenses for the three months ended September 30, 2026, were $31.2 million, a decrease from $33.7 million in the same period of 2025.
• Research and development expenses were $22.3 million for the quarter ended September 30, 2026, compared to $23.0 million in the prior year period, driven by a $6.2 million decrease in clinical trial expenses for studies nearing completion, partially offset by increases in ongoing trial expenses, companion diagnostic development, and personnel costs.
• General and administrative expenses were $8.8 million for the quarter ended September 30, 2026, down from $10.8 million in the prior year period, primarily due to a $2.7 million decrease in personnel-related expenses.
• Net loss for the three months ended September 30, 2026, was $28.8 million ($0.34 per share), compared to a net loss of $26.7 million ($0.37 per share) in the same period of 2025.
• Net loss for the nine months ended September 30, 2026, was $106.5 million ($1.41 per share), compared to $101.8 million ($1.42 per share) in the prior year period.
• Cash, cash equivalents, and marketable securities totaled $228.9 million as of September 30, 2026, compared to $174.6 million as of June 30, 2026.
• Working capital was $204.9 million as of September 30, 2026, compared to $216.6 million as of December 31, 2025.
• Total assets were $270.2 million as of September 30, 2026, compared to $289.0 million as of December 31, 2025.

Guidance and Future Outlook:

• The company expects an integrated topline readout from the DENALI Part 2 study in the first half of 2027.
• Zentalis plans to discuss DENALI data with the FDA in 2027 to assess opportunities for accelerated approval.
• Cash on hand provides a runway into the first half of 2028 to support key milestones, ASPENOVA enrollment, and combination trials.
• The company intends to advance the ASPENOVA Phase 3 trial to support a full approval pathway while simultaneously pursuing an accelerated approval pathway based on DENALI data.

Business Segments and Product Lines:

• DENALI Trial: Enrollment in Parts 2a and 2b is complete; Part 2c enrollment is scheduled to conclude in November 2026. The trial evaluates azenosertib in patients with Cyclin E1-positive platinum-resistant ovarian cancer (PROC).
• ASPENOVA Trial: The Phase 3 global trial is enrolling across multiple geographies to evaluate azenosertib monotherapy versus standard-of-care chemotherapy in Cyclin E1-positive PROC patients.
• MUIR Trial: Enrollment is ongoing for azenosertib in combination with bevacizumab as maintenance treatment for second-line platinum-sensitive ovarian cancer.
• Triple-Negative Breast Cancer: The company is actively planning a combination clinical study for azenosertib in this indication.
• Biomarker Validation: Analytical validation data for a laboratory-developed IHC test for Cyclin E1 detection was presented, demonstrating high concordance across laboratories.
• Clinical Data: At ESMO 2026, median overall survival for Cyclin E1-positive PROC patients (n=48) was 15.9 months versus 7.5 months for Cyclin E1-negative patients (n=46). Updated overall response rate in response-evaluable Cyclin E1-positive patients was 37.2%.

Market and Competitive Landscape:

• Azenosertib is positioned as a potential first-in-class, oral, non-chemotherapy, non-ADC therapy for Cyclin E1-positive PROC, a population comprising approximately 50% of PROC patients with no currently approved specific treatment options.
• The company is evaluating azenosertib in combination with ADCs and other standard-of-care agents to enhance therapeutic benefit across tumor types.

Risks and Challenges:

• The company faces risks related to the regulatory approval process, the potential for clinical trial delays or adverse events, and the possibility that interim data may change upon final audit.
• There is substantial dependence on the success of azenosertib, and the company expects to continue incurring significant losses.
• Risks include the need for additional funding, competition, intellectual property issues, and reliance on third parties.

Management Commentary and Tone:

• CEO Julie Eastland expressed confidence in azenosertib's potential to offer a differentiated oral treatment for Cyclin E1-positive PROC, citing strong overall survival data from DENALI Part 1b.
• Management emphasized a strategy of advancing complementary paths (DENALI and ASPENOVA) to bring the drug to patients quickly, with plans to discuss regulatory strategy with the FDA in 2027.
• The tone reflected confidence in the company's resource position, noting the balance sheet supports execution of key milestones through 2028.

Other Key Points:

• In August 2026, the company completed a follow-on equity offering of 26,450,000 shares, raising approximately $86.9 million in net proceeds.
• The company is advancing a biomarker-driven development strategy using a proprietary immunohistochemistry cutoff for Cyclin E1 protein overexpression.
• The DENALI Part 2 design supports an accelerated approval pathway in the Cyclin E1-positive population, subject to data strength and FDA feedback.
• The ASPENOVA trial is designed to enroll approximately 420 patients and compare azenosertib to investigator's choice of single-agent chemotherapy.