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Zentalis(ZNTL) - 2024 Q1 - Quarterly Report
2024-05-07 11:05
WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 UNITED STATES SECURITIES AND EXCHANGE COMMISSION For the transition period from ___________________ to ___________________ Commission File Number: 001-39263 Zentalis Pharmaceuticals, Inc. (Exact name of registrant as specified in its charte ...
Zentalis(ZNTL) - 2024 Q1 - Quarterly Results
2024-05-07 11:03
[Operational Highlights and Corporate Updates](index=1&type=section&id=Operational%20Highlights%20and%20Corporate%20Updates) 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](index=1&type=chunk)[3](index=3&type=chunk) - 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](index=1&type=chunk)[6](index=6&type=chunk) - Preclinical data presented at **AACR** showed azenosertib's synergistic anti-tumor activity with **KRAS G12C inhibitors**, indicating potential for combination therapies[6](index=6&type=chunk) - Cam Gallagher was appointed as the interim Chief Financial Officer on **April 5, 2024**[7](index=7&type=chunk) [Anticipated Upcoming Milestones](index=2&type=section&id=Anticipated%20Upcoming%20Milestones) 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](index=10&type=chunk) - 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](index=10&type=chunk) - The company targets its first **New Drug Application (NDA)** submission for azenosertib in a gynecologic malignancy in **2026**[10](index=10&type=chunk) [First Quarter 2024 Financial Results](index=2&type=section&id=First%20Quarter%202024%20Financial%20Results) 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](index=2&type=section&id=Financial%20Position%20and%20Expenses) 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](index=1&type=chunk)[9](index=9&type=chunk)[11](index=11&type=chunk) 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](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) 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](index=6&type=section&id=Selected%20Condensed%20Consolidated%20Balance%20Sheet%20Data) 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](index=3&type=section&id=Company%20and%20Product%20Overview) 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](index=12&type=chunk) - 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](index=13&type=chunk)
Zentalis(ZNTL) - 2023 Q4 - Annual Report
2024-02-27 12:08
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM _________ TO _________ Commission File Number: 001-39263 Zentalis Pharmaceuticals, Inc. (Exact name of Registrant as specified in its Charter) Delaware 82-3607803 ...
Zentalis(ZNTL) - 2023 Q4 - Annual Results
2024-02-27 12:04
Exhibit 99.1 Zentalis Pharmaceuticals Reports Full Year 2023 Financial Results and Operational Updates 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 Corporate Updates $483 million cash ...
Zentalis(ZNTL) - 2023 Q3 - Quarterly Report
2023-11-06 14:06
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2023 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ___________________ to ___________________ Commission File Number: 001-39263 Zentalis Pharmaceuticals, Inc. (Exact name of registrant as specified in its ch ...
Zentalis(ZNTL) - 2023 Q2 - Quarterly Report
2023-08-09 11:06
Financial Performance - Total current assets increased to $563,929,000 as of June 30, 2023, compared to $451,933,000 at December 31, 2022, representing a 25% increase[21] - Operating expenses for the three months ended June 30, 2023, were $103,916,000, up 64% from $63,461,000 in the same period of 2022[24] - Net loss for the six months ended June 30, 2023, was $175,826,000, compared to a net loss of $127,629,000 for the same period in 2022, reflecting a 38% increase in losses[27] - Cash and cash equivalents at the end of the period were $266,558,000, significantly up from $43,069,000 at the end of 2022[21] - The company reported a net cash used in operating activities of $128,558,000 for the six months ended June 30, 2023, compared to $93,220,000 for the same period in 2022[30] - The net loss per common share for the three months ended June 30, 2023, was $1.85, compared to $1.34 for the same period in 2022[24] - The net loss attributable to the company for the three months ended June 30, 2023, was $112,527,000, compared to a net loss of $68,357,000 for the same period in 2022, indicating an increase of approximately 64.6%[92] - The company raised a total of $1.2 billion in gross proceeds from the sale of common stock and convertible preferred units since inception, including $250 million from a follow-on offering in June 2023[156] Research and Development - Research and development expenses for the six months ended June 30, 2023, totaled $91,268,000, slightly up from $89,937,000 in the prior year[24] - Research and development (R&D) expenses for Q2 2023 were $42.7 million, a decrease of $1.1 million from $43.8 million in Q2 2022[137] - Azenosertib development costs for the three months ended June 30, 2023, were $13.9 million, while ZN-d5 costs were $5.1 million[127] - Zentera Collaboration Products development costs incurred for the six months ended June 30, 2023, totaled $3.5 million, down from $5.1 million in the same period of 2022[98] - Azenosertib is currently being evaluated in multiple clinical trials, including monotherapy and combinations with chemotherapy and targeted agents[104] - ZN-d5 is being evaluated in multiple clinical trials, including a Phase 1/2 trial for relapsed or refractory light chain amyloidosis with an expected enrollment of approximately 140 patients[111] Equity and Financing - The total stockholders' equity increased to $523,282,000 as of June 30, 2023, from $434,024,000 at December 31, 2022, marking a 21% increase[21] - The company issued common stock resulting in net proceeds of $235,680,000 during the six months ended June 30, 2023[30] - The company completed a follow-on offering on June 15, 2023, issuing 11,032,656 shares at $22.66 per share, generating gross proceeds of approximately $250 million before expenses[78] - Cash, cash equivalents, and marketable securities totaled $553.0 million as of June 30, 2023, expected to fund operations into 2026[113] Collaboration and Licensing - Zentalis terminated its collaboration and license agreements with Zentera Therapeutics, regaining worldwide rights to azenosertib, ZN-d5, and ZN-c5[55] - A $30 million upfront payment was made to Zentera Therapeutics as part of the termination of collaboration agreements, regaining rights for azenosertib, ZN-d5, and ZN-c5 in Greater China[122] - The total consideration for reacquiring the licensed intellectual property from Zentera was $45.6 million, including a fixed payment of $30 million[57] Clinical Trials and Product Development - Azenosertib, a WEE1 inhibitor, has shown a confirmed objective response rate (ORR) of 50.0% in combination with paclitaxel and a median progression-free survival (mPFS) of 7.4 months in patients with Cyclin E1 positive tumors[105] - The company has initiated a Phase 3 study comparing azenosertib dosed intermittently with carboplatin or paclitaxel in patients with Cyclin E1 positive platinum-sensitive ovarian cancer[106] - Azenosertib has received Fast Track designation from the FDA for advanced or metastatic uterine serous carcinoma patients who have undergone prior platinum-based chemotherapy[105] - The company is conducting IND-enabling studies for its BCL-xL product candidate, which targets solid tumors and hematological malignancies[101] Future Outlook and Risks - The company expects to continue incurring significant expenses and operating losses for the foreseeable future[113] - The company currently has no products approved for commercial sale and does not expect to generate revenue from product sales for several years[181][186] - The company will require substantial additional capital to finance operations and may need to delay or reduce research and development programs if unable to raise funds[190] - Market conditions and external factors could adversely impact the company's ability to access capital when needed, potentially affecting its financial condition[193] - The lengthy approval process and unpredictability of clinical trial results may result in failure to obtain regulatory approval for product candidates, significantly harming the company's business and prospects[209]
Zentalis(ZNTL) - 2023 Q1 - Quarterly Report
2023-05-10 11:06
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2023 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ___________________ to ___________________ Commission File Number: 001-39263 Zentalis Pharmaceuticals, Inc. (Exact name of registrant as specified in its charte ...
Zentalis(ZNTL) - 2022 Q4 - Annual Report
2023-03-01 12:11
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM _________ TO _________ Commission File Number: 001-39263 Zentalis Pharmaceuticals, Inc. (Exact name of Registrant as specified in its Charter) Delaware 82-3607803 ...
Zentalis Pharmaceuticals (ZNTL) Investor Presentation - Slideshow
2022-11-23 11:23
zentalis 1 CORPORATE PRESENTATION November 2022 Forward-Looking Statements and Disclaimer Zentalis Pharmaceuticals, Inc. ("we," "us," "our," "Zentalis" or the "Company") cautions that this presentation (including oral commentary that accompanies this presentation) contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. All statements contained in this presentation that do not relate to matters of historical fact should be considered forward-lookin ...
Zentalis Pharmaceuticals (ZNTL) Investor Presentation - Slideshow
2022-08-11 17:53
zentalis C O R P O R AT E P R E S E N TAT I O N A u g u s t 2 0 2 2 Forward-Looking Statements and Disclaimer Zentalis Pharmaceuticals, Inc. ("we," "us," "our," "Zentalis" or the "Company") cautionsthat this presentation (including oral commentary that accompaniesthis presentation) containsforward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. All statements contained in this presentation that do not relate to matters of historical fact should be consider ...