Zentalis Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company focused on the development of small molecule therapeutics for cancer treatment, recently announced its financial results for the quarter ending March 31, 2024, along with key corporate achievements.
Dr. Kimberly Blackwell, the CEO of Zentalis, highlighted the company's progress towards a significant milestone period in late 2024 and into 2025. The company aims to demonstrate the clinical efficacy and safety of azenosertib, its WEE1 inhibitor, across various tumor types. Dr. Blackwell emphasized the potential of azenosertib to meet the unmet needs of patients with severe gynecological cancers, noting the strong momentum in their clinical development plan.
Program Updates and Highlights
Phase 1 Osteosarcoma Study: The results from a Phase 1 trial of azenosertib combined with gemcitabine in adult and pediatric patients with relapsed or refractory osteosarcoma will be showcased at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting.
Preclinical Data on Azenosertib: Zentalis presented preclinical data at the American Association of Cancer Research (AACR) Annual Meeting on April 9, 2024. The data demonstrated that azenosertib shows synergistic anti-tumor activity with KRASG12C inhibitors, indicating potential for combination use with standard cancer treatments.
Ongoing and Planned Clinical Trials: Azenosertib is currently being evaluated in over 10 clinical trials as both a monotherapy and in combination with other treatments. These trials cover a broad spectrum of tumors, including platinum-resistant ovarian cancer, platinum-sensitive ovarian cancer, uterine serous carcinoma, BRAF mutant metastatic colorectal cancer, and other solid tumors. Additionally, Zentalis is investigating azenosertib in combination with its BCL-2 inhibitor (ZN-d5) in patients with relapsed or refractory acute myeloid leukemia (AML).
Corporate Updates
Interim CFO Appointment: On April 5, 2024, Cam Gallagher was appointed interim Chief Financial Officer while the company searches for a permanent CFO.
Upcoming Milestones
- 1H 2024: Presentation of final results from the Phase 1 azenosertib and gemcitabine trial in relapsed or refractory osteosarcoma at the 2024 ASCO Annual Meeting.
- 2H 2024: Presentation of final results from the Phase 1b azenosertib monotherapy trial in solid tumors.
- 2H 2024: Topline data from the Phase 1/2 MAMMOTH trial in partnership with GSK, assessing azenosertib in combination with a PARP inhibitor and as a monotherapy in platinum-resistant ovarian cancer.
- 1H 2025: Topline data from the registration-enabling Phase 2 DENALI study of azenosertib monotherapy in platinum-resistant high-grade serous ovarian cancer.
- 2H 2025: Topline data from the Phase 2 TETON study of azenosertib monotherapy in recurrent or persistent uterine serous carcinoma.
- 2025: Initiation of a registration-enabling trial of azenosertib in the first-line maintenance setting for platinum-sensitive ovarian cancer.
- 2026: Submission of the first New Drug Application (NDA) for azenosertib in a gynecologic malignancy.
First Quarter 2024 Financial Results
Zentalis reported having cash, cash equivalents, and marketable securities amounting to $489.0 million as of March 31, 2024. This includes $56.7 million from Immunome common stock received as part of an out-licensing agreement. The company expects these funds to support its operations into mid-2026. Research and development expenses for the three months ending March 31, 2024, were $49.6 million, a slight increase from $48.6 million in the same period in 2023. General and administrative expenses decreased to $15.7 million from $16.4 million.
About Azenosertib
Azenosertib is an innovative, selective, and orally bioavailable WEE1 inhibitor under investigation for treating ovarian cancer and other tumor types. By inhibiting WEE1, it promotes cell cycle progression even with high DNA damage, leading to cancer cell death.
About Zentalis Pharmaceuticals
Zentalis Pharmaceuticals, Inc. focuses on developing small molecule therapeutics targeting cancer. Their lead product candidate, azenosertib, is a potentially first-in-class WEE1 inhibitor for advanced cancers. The company uses its expertise in cancer biology and medicinal chemistry to further its research and development efforts. Zentalis operates out of New York and San Diego.
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