Zentalis Pharmaceuticals Reports Full Year 2023 Financial Results and Operational Updates
Zentalis Pharmaceuticals, Inc. announces robust azenosertib clinical development plan with multiple clinical catalysts expected in 2024. The company's cash balance stood at $483 million as of December 31, 2023, providing funding into 2026. Key highlights include promising clinical data for azenosertib in ovarian cancer and uterine serous carcinoma, progress in ongoing Phase 1 trials, and strategic leadership team additions.
Positive
Robust clinical development plan for azenosertib with multiple upcoming clinical catalysts in 2024
Promising clinical data for azenosertib in ovarian cancer and uterine serous carcinoma
Cash balance of $483 million as of December 31, 2023, ensuring funding into 2026
Strategic appointments of Diana Hausman, M.D., as Chief Medical Officer, and Kyle Rasbach, Ph.D., Pharm.D., as Chief Business Officer
Strengthened balance sheet through licensing agreement with Immunome
The financial results of Zentalis Pharmaceuticals indicate a strong balance sheet with a cash reserve of $483 million as of December 31, 2023. The company's projected cash runway into 2026 suggests a stable financial position that could reassure investors about the company's ability to fund its operations in the medium term. The increase in research and development expenses to $189.6 million, compared to the previous year, reflects the company's commitment to advancing its clinical development program for azenosertib. This increase is primarily attributed to the termination of a cost-sharing relationship and an uptick in personnel expenses, including non-cash stock-based compensation.
General and administrative expenses have also risen, with a notable non-cash operating lease impairment charge and an increase in personnel costs. The up-front payment of $35 million received from Immunome in January 2024, post the reported period, will further enhance the company's financial strength. It is important to assess whether the increased spending aligns with industry norms for companies at similar stages of drug development and whether it is likely to result in a favorable return on investment, considering the potential market for azenosertib in gynecological malignancies.
The clinical development of azenosertib, a WEE1 inhibitor, is significant due to the unmet medical need in gynecological cancers, such as ovarian cancer and uterine serous carcinoma, which have poor prognoses with current treatments. The reported objective response rate (ORR) of 37% and the median progression-free survival (mPFS) of 6.5 months in a Phase 1 clinical trial are promising indicators of the drug's efficacy. These results could potentially lead to a shift in the standard of care if the data from upcoming trials corroborate these findings.
The company's strategy to evaluate azenosertib across a wide range of tumor types and in combination with other therapies, such as PARP inhibitors and the BEACON regimen, could expand the drug's therapeutic potential. The anticipated New Drug Application (NDA) submission in 2026 for a gynecologic malignancy will be a critical milestone. The medical community will be closely watching the clinical data readouts throughout 2024 and 2025 to assess the drug's safety profile and efficacy across different cancer types.
Zentalis Pharmaceuticals' strategic appointments of Dr. Diana Hausman as Chief Medical Officer and Dr. Kyle Rasbach as Chief Business Officer are aimed at bolstering the company's drug development and business strategy. Dr. Hausman's extensive experience in oncology drug development could provide valuable insights into the clinical strategy for azenosertib, while Dr. Rasbach's background in investment management may enhance the company's business acumen and investor relations.
The licensing agreement with Immunome for the ROR1 antibody drug conjugate and proprietary technology platform, with the potential for up to $275 million in milestone payments and royalties, represents a savvy business move that could provide additional revenue streams. The market will monitor the progress of these collaborations and the impact of leadership changes on the company's trajectory and stock performance.
02/27/2024 - 07:00 AM
Robust azenosertib clinical development plan ongoing and on track with multiple clinical catalysts anticipated, including monotherapy and combination data readouts in gynecological and other cancer types during 2024
Strengthened management team with appointments of Diana Hausman, M.D., as Chief Medical Officer and Kyle Rasbach, Ph.D., Pharm.D., as Chief Business Officer
$483 million cash balance as of December 31, 2023, with projected cash runway into 2026
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
Azenosertib development program updates. In November 2023, the Company announced an updated analysis of the ongoing Phase 1 clinical trial of azenosertib as a monotherapy in solid tumors (ZN-c3-001), which continued to show anti-tumor activity with intermittent dosing. In the same population of 19 platinum resistant or refractory ovarian cancer and uterine serous carcinoma (USC) patients that were included in the data reported on June 6, 2023, the objective response rate (ORR) was 37% . Median follow-up had increased and the median progression free survival (mPFS) had increased to 6.5 months. The Company also disclosed in November 2023, that, with additional safety-evaluable patients and follow-up, azenosertib continued to demonstrate a favorable safety and tolerability profile similar to or better than approved ovarian cancer products. (Link Azenosertib development continues to progress across a broad array of tumor types. Azenosertib is being evaluated in more than 10 ongoing and planned clinical trials as a monotherapy and in combinations supported by compelling scientific rationales across a broad array of tumor types, including platinum resistant ovarian cancer (PROC), platinum sensitive ovarian cancer (PROC), BRAF mutant metastatic colorectal cancer, and other solid tumors. In addition, the Company is evaluating azenosertib and its BCL-2 inhibitor in patients with relapsed or refractory Acute Myeloid Leukemia (AML).On track to disclose multiple clinical data readouts during 2024 and 2025 (anticipated milestones noted below) and on track to submit its first New Drug Application (NDA) for azenosertib in a gynecologic malignancy in 2026.Corporate Updates
Strengthened Leadership Team with the addition of Diana Hausman, M.D. as Chief Medical Officer, and Kyle Rasbach, Ph.D., Pharm.D. as Chief Business Officer. Dr. Hausman is an oncologist with extensive experience in all aspects of drug development and clinical strategy, including over a decade of experience as a Chief Medical Officer at various biopharma companies. During her career, she has contributed to the development of multiple cancer therapeutics, including small molecules, antibody drug conjugates, and immunotherapies. Dr. Rasbach joins from Eventide Asset Management, where he was a Portfolio Manager for Eventide’s healthcare and life sciences strategies, a Managing Director for Eventide Ventures, and a Senior Research Analyst for other Eventide investments. He previously held investment management and equity research roles at several other firms. (Link Strengthened balance sheet with licensing of ROR1 antibody drug conjugate and proprietary technology platform to Immunome. Under the terms of the transaction, in January 2024 Zentalis received an up-front payment of $35 million in cash and Immunome common stock and remains eligible to receive up to $275 million of milestone payments and mid-to-high single-digit royalties. (Link Hosted a webcast with gynecologic oncology academic expert highlighting the strength of the emerging clinical profile for azenosertib . On November 10, 2023, Zentalis participated in a webcast with Joyce F. Liu, M.D., MPH, to discuss azenosertib ovarian cancer clinical data. (Link Anticipated Upcoming Milestones
1H 2024 Final results of Phase 1 azenosertib + chemotherapy (gemcitabine) trial in osteosarcoma (ZN-c3-003) 2H 2024 Final results of Phase 1b azenosertib monotherapy trial in solid tumors (ZN-c3-001) Topline data from Phase 1/2 azenosertib + PARP inhibitor (niraparib) and azenosertib monotherapy trial in platinum resistant ovarian cancer in partnership with GSK (MAMMOTH, ZN-c3-006) Initial data from Phase 1 azenosertib + BEACON regimen (encorafenib + cetuximab) trial in BRAF mutant metastatic colorectal cancer in partnership with Pfizer (ZN-c3-016) Initial data from Phase 1 of azenosertib + ZN-d5 trial in R/R AML (ZN-d5-004C) Additional details on planned clinical trial of azenosertib in PSOC in the 1L maintenance setting 1H 2025 Topline data from Phase 2 azenosertib monotherapy trial in platinum resistant high-grade serous ovarian cancer (DENALI, ZN-c3-005) 2H 2025 Topline data from Phase 2 azenosertib monotherapy trial in recurrent or persistent USC (TETON, ZN-c3-004) 2025 Initiate clinical trial of azenosertib in PSOC in the 1L maintenance setting 2026 First NDA for azenosertib in a gynecologic malignancy Full Year 2023 Financial Results
Cash, Cash Equivalents and Marketable Securities Position : As of December 31, 2023, Zentalis had cash, cash equivalents and marketable securities of $482.9 million . The Company believes that its existing cash, cash equivalents and marketable securities as of December 31, 2023 will be sufficient to fund its operating expenses and capital expenditure requirements into 2026. The December 31, 2023 cash, cash equivalents and marketable securities balance does not reflect the up-front payment from Immunome of $35 million in cash and Immunome stock, which was received in January 2024, as the Company’s agreement was executed and announced in January 2024.Research and Development Expenses : Research and development (R&D) expenses for the year ended December 31, 2023 were $189.6 million , compared to $172.7 million for the year ended December 31, 2022. The increase of $16.9 million was primarily due to a $7.5 million increase in expense relating to our cost sharing relationship with Zentera that was terminated in June 2023, a $7.4 million increase related to personnel expenses, of which $5.8 million related to non-cash stock-based compensation expense, a $2.8 million increase in facilities and overhead expenses and a $2.8 million increase in consulting expense. These increases were partially offset by decreases of $2.8 million and $0.9 million in collaborations expense and supplies/other expenses, respectively.General and Administrative Expenses : General and administrative expenses for the year ended December 31, 2023 were $64.4 million , compared to $54.6 million during the year ended December 31, 2022. The increase of $9.8 million was primarily attributable to a $4.9 million non-cash operating lease impairment charge, a $5.1 million increase related to personnel expenses, of which $3.7 million related to non-cash stock-based compensation expense, and $1.4 million related to outside services. This was partially offset by a $1.6 million decrease in facilities and overhead and other expense.About Azenosertib
About Zentalis Pharmaceuticals ® 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 @ZentalisP www.linkedin.com/company/zentalis-pharmaceuticals
Forward-Looking Statements
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.
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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 $(4.47 ) $(4.48 ) $(3.72 ) Common shares used in computing net loss per share, 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.
What is the cash balance of Zentalis Pharmaceuticals as of December 31, 2023?
Zentalis Pharmaceuticals had a cash balance of $483 million as of December 31, 2023.
Who were the recent appointments made by Zentalis Pharmaceuticals?
Zentalis Pharmaceuticals appointed Diana Hausman, M.D., as Chief Medical Officer, and Kyle Rasbach, Ph.D., Pharm.D., as Chief Business Officer.
What were the key highlights of the clinical data for azenosertib disclosed by Zentalis Pharmaceuticals?
Zentalis Pharmaceuticals disclosed promising clinical data for azenosertib in ovarian cancer and uterine serous carcinoma.
What strategic move did Zentalis Pharmaceuticals make to strengthen its balance sheet?
Zentalis Pharmaceuticals strengthened its balance sheet through a licensing agreement with Immunome, receiving an up-front payment of $35 million in cash and Immunome stock.
Who is the Chief Executive Officer of Zentalis Pharmaceuticals?
The Chief Executive Officer of Zentalis Pharmaceuticals is Kimberly Blackwell, M.D.
