Six sponsored studies with potentially first-in-class Wee1 inhibitor, ZN-c3, ongoing and continuing dose optimization work, as drug continues to show improved tolerability in initial safety data from monotherapy Phase 2 USC trial announced today
Identified Cyclin E driven high-grade serous ovarian cancer patients as initial expansion population for ZN-c3 biomarker monotherapy trial
Announced first ZN-c3 clinical development collaboration with Pfizer in BRAF mutant mCRC; Expanded ZN-c3 clinical development collaboration with GSK in PARP resistant ovarian cancer
Declared BCL-xL protein degrader candidate and initiated IND-enabling studies; Molecule has broad potential across multiple tumor types and in combination
Strengthened Board and management team with appointments of Chief Medical Officer, Chief Scientific Officer and Chief Translational Officer
$422 million cash balance as of September 30, 2022, with projected cash runway into 2025
NEW YORK and SAN DIEGO, Nov. 09, 2022 (GLOBE NEWSWIRE) -- ZentalisTM 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 third quarter ended September 30, 2022 and highlighted recent corporate accomplishments.
“During the third quarter, we made tremendous progress advancing our clinical strategy and corporate capabilities. We have established a three-pronged development plan for ZN-c3, our potentially first-in-class Wee1 inhibitor—investigation as a monotherapy, in combination with chemotherapy, and in combination with targeted therapies,” said Kimberly Blackwell, MD, Chief Executive Officer of Zentalis. “Building on ZN-c3’s favorable safety profile in the monotherapy setting across tumor types, we are pleased to announce Cyclin E gene amplification and protein overexpression as our biomarker strategy in high-grade serous ovarian cancer. This biomarker defined trial in ovarian cancer will allow us to demonstrate potential efficacy in an enriched patient population that has shown evidence of clinical sensitivity to Wee1 inhibition. This trial also has the potential to show initial proof of concept for Wee1 inhibition in Cyclin E driven cancers, which have higher levels of chemotherapy and targeted therapy resistance. On the combination front, there is strong data demonstrating Wee1 inhibition’s synergy with DNA-damaging therapies, such as PARP inhibitors, and with targeted agents in mutationally driven cancers. There is significant interest in these approaches, and we currently have collaborations with Pfizer, GSK and the Dana-Farber Cancer Institute to explore these combinations in the clinic.”
Dr. Blackwell continued, “Our development of ZN-c3 includes ongoing dose optimization activities across the clinical program. Although we have demonstrated a favorable safety profile and monotherapy efficacy when ZN-c3 was given on a continuous daily dosing schedule, data show that higher doses delivered on an intermittent schedule have the potential to lead to higher pharmacokinetic exposures and a more favorable therapeutic index. We believe our dose optimization work will allow us to benefit the broadest range of cancer patients and maximize value for all of our stakeholders. With our strong cash position and strengthened management team, we believe we are well-positioned to execute on our clinical development plans and further our mission to improve the lives of cancer patients.”
Wee1 Inhibitor (ZN-c3) Program Highlights
BCL-2 Inhibitor (ZN-d5) Update
BCL-xL Degrader Update
Corporate Highlights
Third Quarter 2022 Financial Results
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. The Company is developing a focused pipeline of potentially best-in-class oncology candidates, all internally discovered, which include ZN-c3, a potentially first-in-class Wee1 inhibitor for advanced solid and liquid 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 has licensed ZN-c3 and ZN-d5 to its joint venture, Zentera Therapeutics, Ltd. to develop and commercialize these candidates in Greater China, but otherwise retains full economic ownership and control of ZN-c3 and ZN-d5. 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 relating to the potential for a product candidate to be first-in-class and/or best-in-class; the potential benefits of our dose optimization work, including the potential benefit of higher doses delivered on an intermittent schedule; projected cash runway; potential benefits of our product candidates; potential benefits of the Cyclin E biomarker defined trial; our belief we are well-position to execute on our clinical development plans and further our mission to improve the lives of cancer patients; plans to expand our clinical trials, including our Phase 1/2 dose escalation study in ovarian cancer in collaboration with GSK; plans to present preclinical data relating to Cyclin E and the timing thereof; potentially modifying the Phase 2 USC trial dose and the impact of that modification on the timeline of the Phase 2 USC trial; the timing of providing an update on ZN-c3 dosing and the content of that update; the timing of initiation of our clinical trials; and the potential of ZN-c3 to help pancreatic cancer patients. The terms “believe,” “look forward,” “may,” “opportunity,” “optimize,” “plans,” “potential,” “scheduled,” “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 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; the COVID-19 pandemic has adversely impacted and may continue to adversely impact our business, including our preclinical studies and clinical trials; 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 logos 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.
Investor Contacts:
Adam D. Levy, PhD, MBA
alevy@zentalis.com
Alexandra Roy
Solebury Strategic Communications
aroy@soleburystrat.com Zentalis Pharmaceuticals, Inc.Condensed Consolidated Statements of Operations(Unaudited)(In thousands, except per share amounts) Three Months Ended
September 30, Nine Months Ended
September 30, 2022 2021 2022 2021 Operating Expenses Research and development$42,181 $53,998 $132,118 $137,162 General and administrative 12,012 8,872 43,415 31,187 Total operating expenses 54,193 62,870 175,533 168,349 Operating loss (54,193) (62,870) (175,533) (168,349)Other Income (Expense) Investment and other income, net 1,905 99 2,755 313 Gain on deconsolidation of Zentera — 51,582 — 51,582 Net loss before income taxes (52,288) (11,189) (172,778) (116,454)Income tax expense (benefit) (159) (697) (109) (456)Loss on equity method investment 2,371 — 9,460 — Net loss (54,500) (10,492) (182,129) (115,998)Net loss attributable to noncontrolling interests (99) (6,301) (294) (7,332)Net loss attributable to Zentalis$ (54,401) $ (4,191) $ (181,835) $ (108,666)Net loss per common share outstanding, basic and diluted$ (0.96) $ (0.09) $ (3.56) $ (2.59)Common shares used in computing net loss per share, basic and diluted 56,807 44,609 51,098 41,918 Zentalis Pharmaceuticals, Inc.Selected Condensed Consolidated Balance Sheet Data(Unaudited)(In thousands) As of June 30, As of December 31, 2022 2021Cash, cash equivalents and marketable securities $ 421,726 $ 339,887 Working capital (1) 379,829 306,826 Total assets 529,193 454,507 Total liabilities 100,455 90,025 Total Zentalis equity $ 428,738 $ 364,482 (1) The Company defines working capital as current assets less current liabilities.