Zentalis(ZNTL) - 2024 Q1 - Quarterly Results

Operational Highlights and Corporate Updates Zentalis advances azenosertib through clinical trials, with upcoming data presentations and a new interim CFO appointment - The clinical development plan for azenosertib remains on track, with multiple data readouts anticipated in H2 2024 and into 2025, focusing on gynecological and other solid tumors[1][3] - Final results from the Phase 1 study of azenosertib combined with gemcitabine for relapsed or refractory osteosarcoma are slated for presentation at the 2024 ASCO Annual Meeting[1][6] - Preclinical data presented at AACR showed azenosertib's synergistic anti-tumor activity with KRAS G12C inhibitors, indicating potential for combination therapies[6] - Cam Gallagher was appointed as the interim Chief Financial Officer on April 5, 2024[7] Anticipated Upcoming Milestones The company outlines key clinical and regulatory milestones for azenosertib, targeting the first NDA submission by 2026 - Key pipeline catalysts for H2 2024 include final results from the Phase 1b azenosertib monotherapy trial, topline data from the Phase 1/2 MAMMOTH trial in platinum-resistant ovarian cancer, and initial data from Phase 1 trials in BRAF mutant metastatic colorectal cancer and azenosertib + ZN-d5 in R/R AML[10] - Key events for 2025 include topline data from the registration-enabling Phase 2 DENALI study in platinum-resistant ovarian cancer (1H 2025), topline data from the registration-enabling Phase 2 TETON study in uterine serous carcinoma (2H 2025), and initiation of a registration-enabling trial in platinum-sensitive ovarian cancer[10] - The company targets its first New Drug Application (NDA) submission for azenosertib in a gynecologic malignancy in 2026[10] First Quarter 2024 Financial Results Zentalis achieved Q1 2024 net income of $10.1 million from $40.6 million in license revenue, ending with $489.0 million cash projected into mid-2026 Financial Position and Expenses As of March 31, 2024, Zentalis held $489.0 million in cash, projecting a runway into mid-2026, with R&D at $49.6 million and G&A at $15.7 million - The company's cash, cash equivalents, and marketable securities totaled $489.0 million as of March 31, 2024, projected to fund operations into mid-2026[1][9][11] Operating Expenses Comparison (Q1 2024 vs Q1 2023) | Expense Category | Q1 2024 (in millions) | Q1 2023 (in millions) | Change (in millions) | | :--- | :--- | :--- | :--- | | Research & Development | $49.6 | $48.6 | +$1.0 | | General & Administrative | $15.7 | $16.4 | -$0.7 | Condensed Consolidated Statements of Operations Zentalis reported Q1 2024 license revenue of $40.6 million, resulting in a net income of $10.1 million or $0.14 per diluted share Q1 2024 Statement of Operations Highlights (in thousands, except per share data) | Metric | Q1 2024 | Q1 2023 | | :--- | :--- | :--- | | License Revenue | $40,560 | $0 | | Total Operating Expenses | $65,325 | $64,953 | | Loss from Operations | ($24,765) | ($64,953) | | Net Income (Loss) | $10,040 | ($63,262) | | Diluted EPS | $0.14 | ($1.07) | Selected Condensed Consolidated Balance Sheet Data As of March 31, 2024, Zentalis reported total assets of $557.5 million and total liabilities of $98.7 million, with cash increasing to $489.0 million Balance Sheet Highlights (in thousands) | Metric | March 31, 2024 | December 31, 2023 | | :--- | :--- | :--- | | Cash, cash equivalents and marketable securities | $488,984 | $482,919 | | Total Assets | $557,479 | $551,688 | | Total Liabilities | $98,708 | $114,297 | | Total Zentalis Equity | $458,771 | $437,391 | Company and Product Overview Zentalis Pharmaceuticals is a clinical-stage biopharmaceutical company developing small molecule cancer therapeutics, with azenosertib as its lead candidate - Azenosertib is a novel, selective, and orally bioavailable WEE1 inhibitor that induces cancer cell death by accumulating DNA damage through cell cycle checkpoint disruption[12] - The lead product candidate, azenosertib (ZN-c3), is undergoing evaluation as both a monotherapy and in combination therapies for advanced solid tumors and hematologic malignancies[13]