$426.4M cash, cash equivalents and marketable securities as of June 30, 2024; Projected cash runway into mid-2026 SAN DIEGO, Aug. 09, 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 quarter ended June 30, 2024, and highlighted recent corporate accomplishments. "While ...

Core Viewpoint - Zentalis Pharmaceuticals, Inc. is under investigation due to a partial clinical hold placed by the FDA on its studies involving azenosertib, which has led to a decline in its stock price [2]. Investigation Details - On June 18, 2024, Zentalis announced that the FDA had placed a partial clinical hold on three studies: the Phase 1 ZN-c3-001 dose-escalation study in solid tumors, the Phase 2 ZN-c3-005 (DENALI) study in platinum-resistant ovarian cancer, and the Phase 2 ZN-c3-004 (TETON) study in uterine serous carcinoma [2]. Next Steps - Investors who have information related to the investigation or who purchased Zentalis securities are encouraged to assist by visiting the law firm's website or contacting their representatives [3]. Legal Representation - Bronstein, Gewirtz & Grossman, LLC operates on a contingency fee basis, meaning they will only seek reimbursement for expenses and attorney fees if they are successful in the case [4]. Firm Background - Bronstein, Gewirtz & Grossman, LLC is a nationally recognized firm specializing in representing investors in securities fraud class actions and has recovered hundreds of millions of dollars for investors across the nation [5].

NEW YORK, July 25, 2024 /PRNewswire/ -- Kuehn Law, PLLC, a shareholder litigation law firm, is investigating whether certain officers and directors of Zentalis Pharmaceuticals, Inc. (NASDAQ: ZNTL) breached their fiduciary duties to shareholders. The investigation concerns potential self-dealing. Shareholders may be entitled to damages and corporate governance reforms. Why Your Participation Matters: For additional information, please visit Shareholder Derivative Litigation - Kuehn Law. Contacts: Kuehn Law, ...

NEW YORK & SAN DIEGO, June 03, 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 that on June 3, 2024, the Compensation Committee of Zentalis' Board of Directors granted nonqualified stock options to purchase an aggregate of 20,000 shares of the Company's common stock to two newly hired employe ...

Pomerantz LLP, with offices in New York, Chicago, Los Angeles, London, Paris, and Tel Aviv, is acknowledged as one of the premier firms in the areas of corporate, securities, and antitrust class litigation. Founded by the late Abraham L. Pomerantz, known as the dean of the class action bar, Pomerantz pioneered the field of securities class actions. Today, more than 85 years later, Pomerantz continues in the tradition he established, fighting for the rights of the victims of securities fraud, breaches of fid ...

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 ...

[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)

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 ...

Financial Performance - Zentalis Pharmaceuticals reported a cash balance of $483 million as of December 31, 2023, with a projected cash runway into 2026[1]. - Total operating expenses for 2023 were $299.5 million, an increase of 31.8% from $227.3 million in 2022[18]. - The net loss attributable to Zentalis in 2023 was $292.2 million, compared to a net loss of $236.8 million in 2022, representing a 23.4% increase[18]. - The net loss per common share for 2023 was $4.47, slightly improved from $4.48 in 2022[18]. - Cash, cash equivalents, and marketable securities increased to $482.9 million in 2023, up from $437.4 million in 2022[20]. - Total assets as of December 31, 2023, were $551.7 million, compared to $539.3 million in 2022[20]. - Total liabilities increased to $114.3 million in 2023, up from $105.3 million in 2022[20]. - Working capital improved to $427.4 million in 2023, compared to $395.3 million in 2022[20]. - Investment and other income, net, increased significantly to $22.6 million in 2023, compared to $6.0 million in 2022[18]. Research and Development - Research and development expenses for the year ended December 31, 2023, were $189.6 million, an increase of $16.9 million from $172.7 million in 2022[11]. - Azenosertib is being evaluated in over 10 ongoing and planned clinical trials across various tumor types, including ovarian cancer and colorectal cancer[3]. - The objective response rate (ORR) for azenosertib as a monotherapy in a population of 19 patients with platinum-resistant ovarian cancer and uterine serous carcinoma was reported at 37%[3]. - The median progression-free survival (mPFS) for the same patient population increased to 6.5 months[3]. - The company anticipates multiple clinical data readouts during 2024 and 2025, including results from various ongoing trials[4]. - Zentalis is on track to submit its first New Drug Application (NDA) for azenosertib in a gynecologic malignancy in 2026[4]. Administrative and Leadership Changes - General and administrative expenses for the year ended December 31, 2023, were $64.4 million, up from $54.6 million in 2022, reflecting a $9.8 million increase[11]. - General and administrative expenses increased to $64.4 million in 2023, up from $54.6 million in 2022, a rise of 17.5%[18]. - Zentalis strengthened its leadership team with the appointment of Diana Hausman, M.D., as Chief Medical Officer, and Kyle Rasbach, Ph.D., Pharm.D., as Chief Business Officer[7]. Licensing and Collaborations - The company received an upfront payment of $35 million from Immunome for the licensing of a ROR1 antibody drug conjugate, with potential milestone payments of up to $275 million[7].

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 ...