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Sep 30, 2023
Zentalis Q3 2023 Earnings Report
Zentalis reported financial results and provided operational updates
Key Takeaways
Zentalis Pharmaceuticals reported a cash balance of $516.6 million as of September 30, 2023, projecting a cash runway into 2026. The company is focused on advancing azenosertib, with plans to submit the first NDA in a gynecologic malignancy in 2026. Updated data from the azenosertib monotherapy study showed a 37% ORR and mPFS of 6.5 months in heavily pretreated ovarian and uterine serous carcinoma patients.
Azenosertib monotherapy program showed continued anti-tumor activity with intermittent dosing, with a 37% ORR and mPFS of 6.5 months in platinum resistant or refractory ovarian cancer and uterine serous carcinoma patients.
Azenosertib development strategy is on track to submit its first New Drug Application (NDA) for azenosertib in a gynecologic malignancy in 2026.
The company plans to evaluate azenosertib in platinum sensitive ovarian cancer (PSOC) in the first-line (1L) maintenance setting in the clinic.
Mark Lackner, Ph.D., will succeed co-founder, Kevin Bunker, Ph.D., as Chief Scientific Officer at the end of the year.
Zentalis
Zentalis
Forward Guidance
Zentalis anticipates several milestones in the near future, including final results from multiple Phase 1 trials and topline data from Phase 1/2 and Phase 2 trials, as well as initiating a clinical trial of azenosertib in PSOC in the 1L maintenance setting in 2025.
Positive Outlook
- Final results of Phase 1 azenosertib + chemotherapy (gemcitabine) trial in osteosarcoma (ZN-c3-003) in 1H 2024
- Final results of Phase 1b azenosertib monotherapy trial in solid tumors (ZN-c3-001) in 2H 2024
- 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) in 2H 2024
- Initial data from Phase 1 azenosertib + BEACON regimen (encorafenib + cetuximab) trial in BRAF mutant metastatic colorectal cancer in partnership with Pfizer (ZN-c3-016) in 2H 2024
- Topline data from Phase 2 azenosertib monotherapy trial in platinum resistant high-grade serous ovarian cancer (DENALI, ZN-c3-005) in 1H 2025
Challenges Ahead
- Potential delays in clinical trials due to unforeseen events.
- Risks associated with regulatory approval process.
- Dependence on the success of lead product candidates.
- Possibility of product candidates causing serious adverse side effects.
- Inability to maintain collaborations or failure of these collaborations.