NEW YORK and SAN DIEGO, Feb. 27, 2024 (GLOBE NEWSWIRE) -- Zentalis® Pharmaceuticals, Inc. (Nasdaq: ZNTL), a clinical-stage biopharmaceutical company discovering and developing clinically differentiated small molecule therapeutics targeting fundamental biological pathways of cancers, today announced financial results for the year ended December 31, 2023, and highlighted recent corporate accomplishments.
"Zentalis is making remarkable progress in advancing our clinical development program for azenosertib, our potentially groundbreaking WEE1 inhibitor, across various tumor types," stated Kimberly Blackwell, M.D., Chief Executive Officer of Zentalis. "In November 2023, we disclosed promising clinical data demonstrating the potential of azenosertib as an effective monotherapy in ovarian cancer and uterine serous carcinoma. Our team is diligently executing a clinical strategy, which is firmly on track, designed to rapidly bring this promising therapeutic option to patients with gynecological cancers that continue to have a poor prognosis based on currently available treatment options. We anticipate an exciting and data-rich period ahead during the remainder of 2024 and into 2025 where we plan to share multiple clinical datasets to help further demonstrate the potential of azenosertib in multiple cancer types as a monotherapy and in combination."
Program Updates and Highlights
Corporate Updates
Anticipated Upcoming Milestones
Full Year 2023 Financial Results
About Azenosertib
Azenosertib is a potentially first-in-class and best-in-class small molecule WEE1 inhibitor in development for the treatment of cancer. Inhibition of WEE1, a DNA damage response kinase, drives cancer cells into mitosis without being able to repair damaged DNA, resulting in cell death. Currently, there are no FDA-approved WEE1 inhibitors, and azenosertib has been designed for superior selectivity and pharmacokinetic properties. Azenosertib is being developed in therapeutic areas of high unmet need and is being evaluated as a monotherapy, in combination with chemotherapy, and in combination with molecularly targeted agents.
About Zentalis Pharmaceuticals
Zentalis® Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company discovering and developing clinically differentiated small molecule therapeutics targeting fundamental biological pathways of cancers. The Company’s lead product candidate, azenosertib (ZN-c3), is a potentially first-in-class and best-in-class WEE1 inhibitor for advanced solid tumors and hematologic malignancies. Azenosertib is being evaluated as a monotherapy and in combination across multiple clinical trials and has broad franchise potential. In clinical trials, azenosertib has been well tolerated and has demonstrated anti-tumor activity as a single agent across multiple tumor types and in combination with several chemotherapy backbones. As part of its azenosertib clinical development program, the Company is exploring enrichment strategies targeting tumors of high genomic instability, such as Cyclin E1 positive tumors, homologous recombination deficient tumors and tumors with oncogenic driver mutations. The Company is also leveraging its extensive experience and capabilities across cancer biology and medicinal chemistry to advance its research on protein degraders. Zentalis has operations in both New York and San Diego.
For more information, please visit www.zentalis.com. Follow Zentalis on X/Twitter at @ZentalisP and on LinkedIn at www.linkedin.com/company/zentalis-pharmaceuticals.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including statements regarding the potential for azenosertib to be first-in-class and best-in-class; the potential for azenosertib to be groundbreaking across various tumor types; the broad franchise potential of azenosertib; our plans to share multiple clinical datasets to demonstrate the potential of azenosertib in multiple cancer types as a monotherapy and in combination, and the timing thereof; our plans to submit an NDA for azenosertib in a gynecologic malignancy and the timing thereof; the potential for us to receive milestone payments from the Immunome licensing agreement; our plans with respect to the development of our product candidates, including azenosertib and ZN-d5; our plans and timing for the initiation of and the release of data from our clinical trials and our ability to meet other key milestones; the potential benefits of azenosertib, including the potential benefits of the design thereof, the value potential of the asset, and the potential to improve outcomes for patients; and the Company’s cash runway. The terms “advancing,” “anticipate,” “believe,” “continue,” “designed,” “evaluating,” “milestone,” “on track,” “ongoing,” “plan,” “potential,” “projected,” “progress,” “promising,” “strategy,” and similar references are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: our limited operating history, which may make it difficult to evaluate our current business and predict our future success and viability; we have and expect to continue to incur significant losses; our need for additional funding, which may not be available; our plans, including the costs thereof, of development of any diagnostic tools; our substantial dependence on the success of our lead product candidates; the outcome of preclinical testing and early trials may not be predictive of the success of later clinical trials; failure to identify additional product candidates and develop or commercialize marketable products; potential unforeseen events during clinical trials could cause delays or other adverse consequences; risks relating to the regulatory approval process or ongoing regulatory obligations; failure to obtain U.S. or international marketing approval; our product candidates may cause serious adverse side effects; inability to maintain our collaborations, or the failure of these collaborations; our reliance on third parties; effects of significant competition; the possibility of system failures or security breaches; risks relating to intellectual property; our ability to attract, retain and motivate qualified personnel, and risks relating to management transitions; significant costs as a result of operating as a public company; and the other important factors discussed under the caption “Risk Factors” in our most recently filed periodic report on Form 10-K or 10-Q and subsequent filings with the U.S. Securities and Exchange Commission (SEC) and our other filings with the SEC. Any such forward-looking statements represent management’s estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change.
ZENTALIS® and its associated logo are trademarks of Zentalis and/or its affiliates. All website addresses and other links in this press release are for information only and are not intended to be an active link or to incorporate any website or other information into this press release. Comparisons of our product candidates to other agents in this press release are not head-to-head.
Contact:
Carlo Tanzi, Ph.D.
Kendall Investor Relations
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Zentalis Pharmaceuticals, Inc. Consolidated Statements of Operations (In thousands, except per share amounts) | |||||||||
Year ended December 31, | |||||||||
2023 | 2022 | 2021 | |||||||
Operating Expenses | |||||||||
Research and development | $189,590 | $172,734 | $175,601 | ||||||
Zentera in-process research and development | 45,568 | - | - | ||||||
General and administrative | 64,351 | 54,553 | 40,941 | ||||||
Total operating expenses | 299,509 | 227,287 | 216,542 | ||||||
Loss from operations | (299,509 | ) | (227,287 | ) | (216,542 | ) | |||
Other Income (Expense) | |||||||||
Investment and other income, net | 22,617 | 5,987 | 401 | ||||||
Gain on deconsolidation of Zentera | — | — | 51,582 | ||||||
Net loss before income taxes | (276,892 | ) | (221,300 | ) | (164,559 | ) | |||
Income tax expense (benefit) | (601 | ) | (469 | ) | (297 | ) | |||
Loss on equity method investment | 16,014 | 16,282 | 1,831 | ||||||
Net loss | (292,305 | ) | (237,113 | ) | (166,093 | ) | |||
Net loss attributable to noncontrolling interests | (114 | ) | (307 | ) | (7,368 | ) | |||
Net loss attributable to Zentalis | $(292,191 | ) | $(236,806 | ) | $(158,725 | ) | |||
Net loss per common share outstanding, basic and diluted | $(4.47 | ) | $(4.48 | ) | $(3.72 | ) | |||
Common shares used in computing net loss per share, basic and diluted | 65,409 | 52,857 | 42,688 | ||||||
Zentalis Pharmaceuticals, Inc. | ||||
Selected Condensed Consolidated Balance Sheet Data | ||||
(In thousands) | ||||
December 31, | ||||
2023 | 2022 | |||
Cash, cash equivalents and marketable securities | $482,919 | $437,371 | ||
Working capital (1) | 427,351 | 395,286 | ||
Total assets | 551,688 | 539,310 | ||
Total liabilities | 114,297 | 105,286 | ||
Total Zentalis equity | $437,391 | $434,024 | ||
(1) The Company defines working capital as current assets less current liabilities. |
Last Trade: | US$3.00 |
Daily Change: | 0.07 2.39 |
Daily Volume: | 1,747,623 |
Market Cap: | US$213.810M |
December 12, 2024 November 13, 2024 September 16, 2024 August 09, 2024 |
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