Zentalis(US:ZNTL)2025-11-10 21:15Financial Performance - The company reported a net loss of $26,691 thousand for the three months ended September 30, 2025, compared to a net loss of $40,158 thousand for the same period in 2024, indicating an improvement of approximately 33.5%[27] - The net loss per common share for the three months ended September 30, 2025, was $0.37, an improvement from $0.56 for the same period in 2024[27] - The company reported a total comprehensive loss of $26,564 thousand for the three months ended September 30, 2025, compared to a comprehensive loss of $38,704 thousand for the same period in 2024, indicating an improvement of approximately 31.2%[30] - Zentalis reported a net loss of $26.7 million for the three months ended September 30, 2025, compared to a net loss of $40.2 million for the same period in 2024, representing a 33.5% improvement year-over-year[59] - The company incurred a net loss of $165.9 million for the year ended December 31, 2024, with an accumulated deficit of $1.2 billion as of September 30, 2025[108] - The company incurred a net loss of $101.8 million for the nine months ended September 30, 2025, compared to a net loss of $118.4 million for the same period in 2024[170] Assets and Liabilities - Total current assets decreased from $386,066 thousand as of December 31, 2024, to $288,302 thousand as of September 30, 2025, representing a decline of approximately 25.3%[24] - The total liabilities decreased from $93,151 thousand as of December 31, 2024, to $74,376 thousand as of September 30, 2025, a reduction of approximately 20.1%[24] - Total stockholders' equity decreased from $337,186 thousand as of December 31, 2024, to $252,874 thousand as of September 30, 2025, a decline of approximately 25.0%[24] - As of September 30, 2025, the estimated fair value of available-for-sale marketable securities was $239.2 million, with a gross unrealized loss of $44 thousand[60] - The company had $10.81 million in prepaid expenses and other assets as of September 30, 2025, a decrease from $14.39 million as of December 31, 2024[68] - Accrued expenses totaled $30.64 million as of September 30, 2025, down from $46.13 million as of December 31, 2024[71] Cash Flow and Investments - Cash and cash equivalents increased from $33,901 thousand as of December 31, 2024, to $39,072 thousand as of September 30, 2025, marking an increase of approximately 15.3%[24] - Cash used in operating activities for the nine months ended September 30, 2025, was $94,307 thousand, compared to $131,150 thousand for the same period in 2024, reflecting a decrease of approximately 28.1%[33] - Net cash used in operating activities for the nine months ended September 30, 2025 was $94.3 million, compared to $131.2 million for the same period in 2024, reflecting a decrease of approximately 28.1%[147][148] - Net cash provided by investing activities for the nine months ended September 30, 2025 was $99.2 million, down from $144.3 million in 2024, a decrease of approximately 31.3%[149][150] Research and Development - Research and development expenses for the nine months ended September 30, 2025, were $77,807 thousand, down from $134,795 thousand in the same period of 2024, reflecting a decrease of approximately 42.2%[27] - Research and development expenses for Q3 2025 were $22.95 million, a decrease of $13.87 million from $36.82 million in Q3 2024[130] - The company anticipates an increase in research and development expenses as it prepares for a planned Phase 3 study of azenosertib[120] - The company is focused on developing a first-in-class WEE1 inhibitor, azenosertib (ZN-c3), for patients with Cyclin E1-positive platinum-resistant ovarian cancer[45] Licensing and Revenue - The company had no license revenue for the three months ended September 30, 2025, compared to $40,560 thousand for the nine months ended September 30, 2024[27] - The company recognized revenue from milestone payments of $5.0 million during the twelve months ended December 31, 2024, related to the Immunome Asset Purchase Agreements[56] - Zentalis entered into an exclusive license agreement with Immunome in January 2024, receiving upfront consideration of $40.6 million, which included $15.0 million in cash and approximately $25.6 million in Immunome common stock[52] Stock and Equity - The company had 11,460,519 shares subject to outstanding awards under the 2020 Incentive Award Plan as of September 30, 2025[73] - As of September 30, 2025, there were 6,665,630 shares subject to outstanding awards under the 2022 Inducement Plan, with 1,912,370 shares available for future grants[75] - Total share-based compensation expense for the three months ended September 30, 2025, was $4,828,000, a decrease of 53.5% from $10,362,000 in the same period of 2024[76] Future Outlook and Risks - The company expects to incur significant expenses and increasing operating losses for the foreseeable future due to ongoing research and development efforts for azenosertib and future product candidates[171] - The company may enter into collaborations with third parties for product development, but the success of these collaborations is uncertain and could affect market potential[183] - The company faces risks related to market volatility, public health emergencies, and economic issues that could impact its ability to access capital[179] - The company has not yet submitted for regulatory approval for any product candidate, including azenosertib, which may never obtain approval[193] Clinical Development - Azenosertib is being evaluated in multiple clinical trials, including a Phase 3 trial against standard-of-care chemotherapy for Cyclin E1-positive PROC[101] - The company is collaborating with diagnostic partners for the development of a companion diagnostic for azenosertib, which is essential for identifying patients with Cyclin E1-positive PROC[175] - The FDA will not approve a therapeutic product if the essential companion diagnostic is not also approved, impacting the development of azenosertib for Cyclin E1-positive PROC[209]