Zentalis Pharmaceuticals, Inc. (ZNTL) appears an attractive pick, as it has been recently upgraded to a Zacks Rank #1 (Strong Buy). An upward trend in earnings estimates -- one of the most powerful forces impacting stock prices -- has triggered this rating change.The sole determinant of the Zacks rating is a company's changing earnings picture. The Zacks Consensus Estimate -- the consensus of EPS estimates from the sell-side analysts covering the stock -- for the current and following years is tracked by th ...

Core Insights - The FDA has granted Fast Track Designation to azenosertib for treating platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer in patients positive for Cyclin E1 [1][2] - Azenosertib is a selective WEE1 inhibitor being evaluated as a monotherapy and in combination therapies for various cancers, with a focus on gynecological malignancies [5][7] - A corporate event is scheduled for January 29, 2025, to present clinical data and regulatory updates regarding azenosertib [4] Company Overview - Zentalis Pharmaceuticals is a clinical-stage biopharmaceutical company focused on developing small molecule therapeutics targeting cancer pathways [7] - The lead product candidate, azenosertib, is positioned as a potentially first-in-class WEE1 inhibitor with broad franchise potential across multiple tumor types [7] - The company is exploring strategies to enrich patient populations for clinical trials, particularly targeting tumors with high genomic instability [7] Clinical Development - Azenosertib is currently being evaluated in several clinical trials, including monotherapy and combination studies, with a focus on high-grade serous ovarian cancer and PARP-resistant PROC [5][6] - The Phase 2 DENALI study has enrolled 102 patients, while the Phase 1b ZN-c3-001 trial has reported results from 69 PROC patients [5] - Initial data from the Phase 1 ZN-c3-016 trial in BRAF mutant metastatic colorectal cancer is also being presented [5] Research and Findings - Recent research published in npj Precision Oncology highlights the role of Cyclin E1/CDK2 activation in predicting sensitivity to azenosertib, supporting a biomarker-directed strategy for patient selection [2][3] - Preclinical models with high Cyclin E1 activation levels show increased sensitivity to azenosertib, indicating potential for targeted treatment approaches [3]

Financial Performance - License revenue for the nine months ended September 30, 2024, was $40.6 million, with no revenue reported for the same period in 2023[11] - Total operating expenses for the three months ended September 30, 2024, were $51.4 million, down from $62.7 million in the same period of 2023, a reduction of approximately 17.5%[11] - Research and development expenses for the nine months ended September 30, 2024, were $134.8 million, compared to $138.0 million for the same period in 2023, a decrease of about 2.3%[11] - Net loss for the three months ended September 30, 2024, was $40.2 million, compared to a net loss of $55.5 million for the same period in 2023, reflecting an improvement of approximately 27.5%[11] - Total comprehensive loss for the nine months ended September 30, 2024, was $118,995,000, compared to $230,372,000 for the same period in 2023, indicating a 48.3% reduction[13] - The company reported a net loss attributable to Zentalis of $118,967,000 for the nine months ended September 30, 2024, compared to $230,280,000 for the same period in 2023, a 48.3% decrease[19] - Net loss attributable to Zentalis for the three months ended September 30, 2024, was $40.158 million, compared to a loss of $55.528 million for the same period in 2023, representing a 27.3% improvement[79] Assets and Liabilities - Total current assets decreased from $496.7 million as of December 31, 2023, to $400.3 million as of September 30, 2024, representing a decline of approximately 19.4%[9] - Total liabilities decreased from $114.3 million as of December 31, 2023, to $96.3 million as of September 30, 2024, a decline of approximately 15.8%[9] - Cash, cash equivalents, and restricted cash at the end of the period totaled $43,947,000, down from $113,370,000 at the end of September 2023[16] - The balance of cash and cash equivalents decreased from $110,750,000 in September 2023 to $41,320,000 in September 2024[16] - Zentalis' total equity as of September 30, 2024, was $354,331,000, down from $437,391,000 at the end of December 2023[18] Cash Flow - Net cash used in operating activities for the nine months ended September 30, 2024, was $131,158,000, compared to $167,220,000 for the same period in 2023, reflecting a 21.5% decrease[14] - The company recorded lease income of $1.1 million from a sublease agreement for the nine months ended September 30, 2024[78] Shareholder Equity and Stock - The company completed a follow-on offering on June 15, 2023, raising approximately $250.0 million by issuing 11,032,656 shares at $22.66 per share[62] - Zentalis issued 30 shares under the employee stock purchase plan, raising $92,000 in additional paid-in capital during the three months ended September 30, 2024[18] - The company recorded share-based compensation expenses of $35,906,000 for the nine months ended September 30, 2024, compared to $40,940,000 for the same period in 2023[14] - Share-based compensation expense for the three months ended September 30, 2024, was $10,362 thousand, compared to $13,867 thousand for the same period in 2023, reflecting a decrease of approximately 25%[66] Product Development and Future Outlook - The company is substantially dependent on the success of its lead product candidate, azenosertib, for future revenue generation[8] - Zentalis' lead product candidate, azenosertib, is a WEE1 inhibitor targeting advanced solid tumors and hematologic malignancies[23] - The company is eligible to receive up to $275 million in development, regulatory, and sales milestones from the Immunome Agreements[37] - In October 2024, the company entered into an asset purchase agreement with Immunome, selling ZPC-21 and its proprietary ADC platform technology for approximately $21.9 million in shares and $5.0 million contingent upon developmental milestones[83] Marketable Securities and Investments - Total available-for-sale marketable securities amounted to $349.93 million as of September 30, 2024, with unrealized gains of $1.64 million[48] - The estimated fair value of available-for-sale marketable securities was $454.88 million as of December 31, 2023[53] - The company recorded equity investment gains of $5.7 million and $7.9 million during the three and nine months ended September 30, 2024, respectively[53] Other Financial Information - The company has incurred significant net losses since inception and expects to continue incurring losses for the foreseeable future[8] - The company has no substantial doubt about its ability to continue as a going concern within one year from the financial statement issuance date[24] - There have been no significant changes to the company's disclosures regarding market risk since the last annual report[84]

Overview of FMR LLC's Transaction - FMR LLC reduced its holdings in Zentalis Pharmaceuticals by 3,600,886 shares, bringing the total to 5,075,837 shares as of September 30, 2024, at a price of $3.68 per share [1] - This reduction reflects a strategic shift in FMR LLC's investment approach towards Zentalis Pharmaceuticals [1] Company Profile: Zentalis Pharmaceuticals - Zentalis Pharmaceuticals is focused on developing cancer therapeutics using its Integrated Discovery Engine to create small molecule new chemical entities [4] - The company has a market capitalization of $221.145 million and a current stock price of $3.11, indicating a significant decline from its IPO price [4] Financial Performance and Market Context - Zentalis Pharmaceuticals has faced a year-to-date price decline of 80.55% and an 87.56% drop since its IPO, highlighting the volatility in biotechnology investments [5] - The company's GF-Score is 31/100, indicating challenges in profitability and growth [5][6] Investment Implications - The decision by FMR LLC to reduce its stake in Zentalis is likely due to the company's poor financial and market performance [6] - The biotechnology sector remains competitive, and Zentalis must leverage its R&D to improve its financial standing and market position [6] Future Outlook - The prospects for Zentalis in the biotechnology sector appear cautious, necessitating critical evaluations of its pipeline products and market strategies [6] - Investors will be closely monitoring how Zentalis navigates its upcoming development phases and market adaptations [7]

Shares of Zentalis Pharmaceuticals (ZNTL) gained 13.6% on Monday after it announced that the FDA has lifted the partial clinical hold previously imposed on three studies of the company's lead product candidate, azenosertib, for three different cancer indications. The decision was based on the regulatory body's review of Zentalis' complete response package, which included a comprehensive safety assessment of the azenosertib program. Zentalis' azenosertib, a potentially first-in-class oral WEE1 inhibitor, is ...

Monday, the FDA lifted the partial clinical hold on studies of Zentalis Pharmaceuticals, Inc.'s ZNTL azenosertib, the company's novel, selective, and orally bioavailable inhibitor of WEE1. The FDA has cleared the company to resume enrollment in all ongoing azenosertib clinical studies with no changes in the clinical development plan. Zentalis will be working with clinical trial investigators to resume study activities across the azenosertib development program as quickly as possible. Also Read: Zentalis Gea ...

SAN DIEGO, Sept. 16, 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 the U.S. Food and Drug Administration (FDA) has lifted the partial clinical hold on studies of azenosertib, the Company's novel, selective, and orally bioavailable inhibitor of WEE1. The FDA has cleared the Company to r ...

Company Overview - Zentalis Pharmaceuticals, Inc. (ZNTL) has experienced a significant stock decline of 71.7% over the past three months, contrasting with the industry growth of 6.2% [1] - The company is focused on developing azenosertib, a potential first-in-class WEE1 inhibitor, for various cancer treatments, including solid tumors and ovarian cancer [1] Clinical Trials and Regulatory Actions - In June 2024, the FDA imposed a partial clinical hold on three studies evaluating azenosertib for different cancer indications due to safety concerns [2][3] - The studies affected include the phase I ZN-c3-001 for solid tumors, the phase II ZN-c3-005 DENALI for platinum-resistant ovarian cancer, and the phase II ZN-c3-004 TETON for uterine serous carcinoma [2] - The hold was triggered after two patient deaths in the DENALI study, presumed to be due to sepsis, which likely contributed to the stock's decline [3] Upcoming Data and Studies - Top-line data from cohort 1b of the DENALI study is anticipated in the second half of 2024, with additional data from the ZN-c3-001 and MAMMOTH studies expected later this year [3][6] - The phase I/II MAMMOTH study is evaluating azenosertib in combination with GSK's PARP inhibitor Zejula and as a monotherapy for treating platinum-resistant ovarian cancer [4] Financial Position - As of June 30, 2024, Zentalis reported cash, cash equivalents, and marketable securities totaling $426.4 million, which is projected to fund operations into mid-2026 [6] Recent Developments - Zentalis has discontinued the development of its BCL-2 inhibitor, ZN-d5, which was being evaluated in combination with azenosertib for acute myeloid leukemia [5]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 Title of each class Trading Symbol(s) Name of each exchange on which registered Common Stock, $0.001 par value per share ZNTL The Nasdaq Stock Market LLC (The Nasdaq Global Market) 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 June 30, 2024 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the tra ...

Exhibit 99.1 Zentalis Pharmaceuticals Reports Second Quarter 2024 Financial Results and Operational Progress $426.4M cash, cash equivalents and marketable securities as of June 30, 2024; Projected cash runway into mid-2026 SAN DIEGO — August 9, 2024 — 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 ...