NEW YORK and SAN DIEGO, May 10, 2023 (GLOBE NEWSWIRE) -- Zentalis® Pharmaceuticals, Inc. (Nasdaq: ZNTL), a clinical-stage biopharmaceutical company focused on discovering and developing clinically differentiated small molecule therapeutics targeting fundamental biological pathways of cancers, today announced financial results for the quarter ended March 31, 2023, and highlighted recent corporate accomplishments.
“We believe that azenosertib has the potential to benefit large numbers of patients who are facing difficult-to-treat cancers. As a result, our highest priority remains the successful execution of our development strategy for this promising therapeutic,” said Kimberly Blackwell, M.D., Chief Executive Officer of Zentalis. “We began the year by initiating enrollment in our Pfizer-partnered clinical trial combining azenosertib with the BEACON regimen in BRAF V600E mutant metastatic colorectal cancer. At AACR in April, we presented preclinical data supporting the use of CCNE1 amplification and/or Cyclin E1 expression as a potential marker for the enrichment of patient populations for treatment with azenosertib. We are driving toward two additional milestones for azenosertib in the first half of the year – disclosing our monotherapy dose, and sharing positive clinical data from our chemotherapy combination trial in ovarian cancer at ASCO in June.”
The Company also announced the appointment of Diana Hausman, M.D., to the Board of Directors. “I share Zentalis’ passion and commitment to developing therapeutics for difficult-to-treat cancers,” said Dr. Hausman. “I believe azenosertib has the potential to be a game-changing therapeutic for cancer patients, and I look forward to working with the other members of the Board and the Zentalis management team to help the Company achieve its goals.”
WEE1 Inhibitor (Azenosertib) Program Highlights
BCL-2 Inhibitor (ZN-d5) 2023 Milestones
Corporate Highlights
First Quarter 2023 Financial Results
About Azenosertib
Zentalis’ azenosertib (ZN-c3) has been designed to be a highly potent and selective WEE1 inhibitor. Azenosertib is currently being evaluated in the clinic for advanced solid tumors and hematological malignancies in the following three therapeutic settings of high unmet medical need: (1) as a monotherapy, (2) in combination with traditional chemotherapy and DNA damaging agents, and (3) in combination with molecularly targeted agents. As a monotherapy, azenosertib is currently being evaluated in a Phase 2 clinical trial in adult women with uterine serous carcinoma (USC), an aggressive form of endometrial cancer that accounts for approximately 10-15% of all endometrial cancers. We are also evaluating azenosertib as a monotherapy in a Phase 2 clinical trial in patients with Cyclin E1 driven high-grade serous ovarian cancer (HGSOC). The Company is evaluating azenosertib as a monotherapy in a Phase 1 dose optimization clinical trial in patients with advanced solid tumors, and plans to disclose the monotherapy dose and provide an update on dose optimization activities in the first half of 2023. In chemotherapy combinations, azenosertib is currently being evaluated in combination with each of paclitaxel, carboplatin, pegylated liposomal doxorubicin (PLD) and gemcitabine in four cohorts in a Phase 1b clinical trial in patients with advanced platinum-resistant ovarian, peritoneal or fallopian tube cancer. The Company plans to disclose results from this study in the first half of 2023, in advance of original guidance. Azenosertib is also currently being evaluated in combination with gemcitabine in a Phase 1/2 clinical trial in adult and pediatric patients with relapsed or refractory osteosarcoma. In combination with molecularly targeted agents, the Company is studying azenosertib in combination with GlaxoSmithKline plc's (GSK’s) PARP inhibitor, niraparib (ZEJULA®), in a Phase 1/2 clinical trial in platinum-resistant ovarian cancer patients who have failed PARP inhibitor maintenance treatment as part of a clinical collaboration with GSK. The Company is also collaborating with Pfizer Inc. to evaluate azenosertib in combination with encorafenib and cetuximab, an FDA-approved standard of care known as the BEACON regimen, in patients with BRAF V600E mutant metastatic colorectal cancer in a Phase 1/2 clinical trial.
About Zentalis Pharmaceuticals
Zentalis® Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company focused on discovering and developing small molecule therapeutics targeting fundamental biological pathways of cancers. Utilizing its Integrated Discovery Engine, the Company is developing a focused pipeline of potentially best-in-class oncology candidates, which include azenosertib (ZN-c3), a WEE1 inhibitor for advanced solid tumors, ZN-d5, a BCL-2 inhibitor for hematologic malignancies and related disorders, and a heterobifunctional degrader of BCL-xL for solid and hematological malignancies. 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 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 timing of our announcement of a monotherapy dose and other development updates for azenosertib; the potential for azenosertib to be first-in-class and best-in-class; plans to present at scientific conferences; projected cash runway; the potential for azenosertib to benefit large numbers of patients who are facing difficult-to-treat cancers; the commercial potential of our product candidates; the potential for the use of CCNE1 amplification and/or Cyclin E1 expression as a marker for the enrichment of patient populations for treatment with azenosertib; the timing and content of upcoming milestones for azenosertib; the potential for azenosertib to be a game-changing therapeutic for cancer patients; the potential for the Company to achieve its goals; the goals of azenosertib dose optimization activities and the potential clinical benefits of those activities; the potential for our product candidates to be best-in-class; the timing of disclosure of clinical data; the timing of disclosing the monotherapy dose for ZN-d5; the potential benefits of azenosertib, including the potential benefits of the design of azenosertib; the potential benefits of our collaborations, including with Foundation Medicine and Roche Diagnostics. The terms “believe,” “can,” “design,” “driving,” “expect,” “goal,” “look forward,” “milestone,” “on track,” “plan,” “potential,” “promising,” “project,” “provide,” “support,” “to be,” “will” 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.
Dr. Meric-Bernstam receives compensation as a member of the Zentalis Scientific Advisory Board, and this financial relationship has been disclosed to MD Anderson’s Conflict of Interest Committee in accordance with its institutional policy.
Investor Contacts:
Adam D. Levy, PhD, MBA
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Alexandra Roy
Solebury Strategic Communications
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Media Contact:
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Solebury Strategic Communications
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Zentalis Pharmaceuticals, Inc. | |||||||
Condensed Consolidated Statements of Operations | |||||||
(Unaudited) | |||||||
(In thousands, except per share amounts) | |||||||
Three Months Ended March 31, | |||||||
2023 | 2022 | ||||||
Operating Expenses | |||||||
Research and development | $ | 48,584 | $ | 46,112 | |||
General and administrative | 16,369 | 11,767 | |||||
Total operating expenses | 64,953 | 57,879 | |||||
Operating loss | (64,953 | ) | (57,879 | ) | |||
Other Income (Expense) | |||||||
Investment and other income, net | 4,109 | 426 | |||||
Net loss before income taxes | (60,844 | ) | (57,453 | ) | |||
Income tax expense | 108 | 33 | |||||
Loss on equity method investment | 2,310 | 1,751 | |||||
Net loss | (63,262 | ) | (59,237 | ) | |||
Net loss attributable to noncontrolling interests | (43 | ) | (160 | ) | |||
Net loss attributable to Zentalis | $ | (63,219 | ) | $ | (59,077 | ) | |
Net loss per common share outstanding, basic and diluted | $ | (1.07 | ) | $ | (1.31 | ) | |
Common shares used in computing net loss per share, basic and diluted | 59,277 | 45,244 | |||||
Zentalis Pharmaceuticals, Inc. | ||||||
Selected Condensed Consolidated Balance Sheet Data | ||||||
(Unaudited) | ||||||
(In thousands) | ||||||
As of March 31, | As of December 31, | |||||
2023 | 2022 | |||||
Cash, cash equivalents and marketable securities | $ | 392,519 | $ | 437,371 | ||
Working capital (1) | 353,868 | 395,286 | ||||
Total assets | 489,342 | 539,310 | ||||
Total liabilities | 103,677 | 105,286 | ||||
Total Zentalis equity | $ | 385,665 | $ | 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 |
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