Financial Data and Key Metrics Changes - The company is focused on completing its registration trials, particularly the DENALI study for asenosertib in patients with cyclin E1 protein overexpression in platinum-resistant ovarian cancer [5][6] - The response rates observed in the DENALI trial were significantly higher than standard care chemotherapy, indicating a potential for better outcomes in a patient population with historically poor responses [12][13] Business Line Data and Key Metrics Changes - The primary focus is on the development of asenosertib, which is positioned as a first-in-class oral non-chemotherapy option for patients [5][6] - The company is conducting a seamless design for the DENALI trial, allowing for continuous enrollment while confirming the optimal dose [14][15] Market Data and Key Metrics Changes - The company estimates that at least 50% of the platinum-resistant ovarian cancer (PROC) setting would be eligible for treatment with asenosertib, indicating a substantial market opportunity [41] - The market opportunity for asenosertib is projected to be larger than that of mirvetuximab, with potential peak sales estimated at around $2 billion [42][43] Company Strategy and Development Direction - The company aims to focus resources on getting asenosertib to market while exploring opportunities for combination therapies with other agents, including antibody-drug conjugates (ADCs) [34][56] - There is a strategic emphasis on educating the market and physicians about the unique benefits of asenosertib, particularly in biomarker-selected populations [6][31] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the ongoing enrollment in the DENALI trial and the enthusiasm from physicians regarding the non-chemotherapy oral option [28][29] - The company is committed to maintaining a clear narrative and strategy to address any concerns stemming from past clinical holds and to ensure investor confidence [50][51] Other Important Information - The company is preparing for top-line data from the DENALI trial in 2026, which is crucial for accelerated approval discussions with regulatory agencies [59][60] - There is ongoing interest in potential partnerships to expand the reach of asenosertib and explore combination therapies [56][57] Q&A Session Summary Question: What are the expectations for the DENALI trial data? - The company anticipates that the DENALI trial will yield response rates similar to or better than historical data, with a focus on biomarker-selected patients [17][24] Question: How does the company view the market opportunity for asenosertib? - The company believes that asenosertib could capture a significant portion of the PROC market, potentially exceeding the market share of mirvetuximab [41][42] Question: What is the company's strategy regarding combination therapies? - The company is exploring combinations with ADCs and other agents, emphasizing the importance of synergistic effects and managing tolerability profiles [32][34] Question: How is the company addressing past clinical holds? - Management is focused on improving communication and education regarding the safety profile of asenosertib to alleviate concerns from investors and the medical community [50][51] Question: What are the key milestones moving forward? - Key milestones include top-line data from the DENALI trial, discussions with regulatory agencies regarding phase three design, and updates on other ongoing studies [59][60]

Zentalis Pharmaceuticals (ZNTL) FY 2025 Conference May 20, 2025 11:30 AM ET Speaker0 Great. I'd like to welcome everybody back to our morning session. I'd like to welcome everybody again to the H. C. Wainwright BioConnect Investor Conference at Nasdaq. Presenting, with us next is Zentalis Pharmaceuticals, and we have chief executive officer and president Julie Eastland, and we have Zentalis' CMO, Igmar Ber Burns Bruns. Welcome, and it's my pleasure to host you today. Speaker1 Thanks for having us as always ...