Zentalis Pharmaceuticals Files 8-K Report

Ticker: ZNTL · Form: 8-K · Filed: Jan 29, 2025 · CIK: 1725160

Sentiment: neutral

Topics: 8-K, SEC Filing, Disclosure

Related Tickers: ZNTL

TL;DR

ZNTL filed an 8-K on Jan 29, 2025 - check for updates.

AI Summary

On January 29, 2025, Zentalis Pharmaceuticals, Inc. filed an 8-K report. The filing primarily concerns Regulation FD disclosures and other events, along with financial statements and exhibits. No specific material events or financial figures were detailed in the provided excerpt.

Why It Matters

This filing indicates Zentalis Pharmaceuticals is providing updates or disclosures to the SEC, which could contain material information for investors.

Risk Assessment

Risk Level: low — The provided excerpt is a standard 8-K filing notification and does not contain specific material events or financial data that would indicate a change in risk.

Key Players & Entities

FAQ

What specific event triggered this 8-K filing?

The filing indicates it is for Regulation FD Disclosure, Other Events, and Financial Statements and Exhibits, but the specific triggering event is not detailed in the excerpt.

What is the primary purpose of this 8-K filing for Zentalis Pharmaceuticals?

The filing serves to report current information to the SEC, including potential Regulation FD disclosures, other significant events, and financial statements/exhibits.

When was this 8-K report filed with the SEC?

The report was filed on January 29, 2025.

What is Zentalis Pharmaceuticals' Standard Industrial Classification (SIC) code?

Zentalis Pharmaceuticals' SIC code is 2834, which corresponds to Pharmaceutical Preparations.

Does this filing provide any new financial results for Zentalis Pharmaceuticals?

The excerpt mentions 'Financial Statements and Exhibits' but does not provide specific financial results or figures within this section.

Filing Stats: 2,388 words · 10 min read · ~8 pages · Grade level 12.4 · Accepted 2025-01-29 09:18:14

Key Financial Figures

Filing Documents

01 Regulation FD Disclosure

Item 7.01 Regulation FD Disclosure. On January 29, 2025, Zentalis Pharmaceuticals, Inc. ("Zentalis" or the "Company") issued the press release furnished as Exhibit 99.1 to this Current Report on Form 8-K (this "Current Report") and incorporated herein by reference. In addition, on January 29, 2025, spokespersons for the Company presented the information in the Corporate Event Presentation furnished as Exhibit 99.2 to this Current Report, and incorporated herein by reference, at the Company's corporate event on January 29, 2025 (the "Corporate Event") and plan to present the information in the Corporate Event Presentation in meetings with investors and analysts. The Corporate Event was presented via live webcast, and an archived recording is available under the "Events & Presentations" tab on the "Investors & Media" section of the Company's website. The information contained in Item 7.01 of this Current Report (including Exhibits 99.1 and 99.2 attached hereto) shall not be deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), or otherwise subject to the liabilities of that section, nor shall they be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, whether made before or after the date hereof, except as expressly provided by specific reference in such a filing.

01 Other Events

Item 8.01 Other Events. Azenosertib Development Plan for PROC Monotherapy On January 29, 2025, the Company announced that it would, as an initial matter, focus its development efforts for its WEE1 inhibitor product candidate, azenosertib, on patients with platinum-resistant ovarian cancer ("PROC") whose tumors are Cyclin E1-positive as determined utilizing an immunohistochemistry ("IHC") assay and Zentalis' proprietary IHC cutoff. The Company has aligned with the U.S. Food and Drug Administration ("FDA") on the design of its DENALI Part 2 study in patients with Cyclin E1-positive PROC, which allows for seamless enrollment across Parts 2a and 2b: Part 2a is designed to confirm the primary dose-of-interest, 400mg QD 5:2 (intermittent daily dosing on a five days on, two days off schedule), with a target enrollment of approximately 30 patients at each of two dose levels: 400mg QD 5:2 and 300mg QD 5:2. Part 2b is designed to enroll approximately 70 patients at a single dose, the selection of which will be informed by the Part 2a results, with the final Part 2b dose selection and endpoints subject to FDA feedback. The Company plans to initiate enrollment of DENALI Part 2 in the first half of 2025 and to disclose topline data from DENALI Part 2 by year end 2026. DENALI Part 2, if successful, has the potential to support an accelerated approval, subject to FDA review. Azenosertib Clinical Results Also on January 29, 2025, the Company announced certain clinical results for azenosertib, including the following: ZN-c3-001: ZN-c3-001 is a Phase 1, dose-escalation study that evaluated azenosertib monotherapy in solid tumors across continuous and intermittent dosing schedules. ZN-c3-001 is fully enrolled (n=274). Greater anti-tumor activity was seen with intermittent dose schedules and in Cyclin E1-positive patients. There were 23 patients with Cyclin E1-positive PROC who were dosed at intermittent schedules at total daily doses of 300mg. In these patients as of the

01 Financial Statements and Exhibits

Item 9.01 Financial Statements and Exhibits. (d) Exhibits The following Exhibits 99.1 and 99.2 relating to Item 7.01 shall be deemed to be furnished, and not filed: Exhibit No. Description 99.1 Press Release issued on January 29, 2025. 99.2 Corporate Event Presentation, dated January 29, 2025. 104 Cover Page Interactive Data File (embedded within the inline XBRL document)

SIGNATURES

SIGNATURES Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized. ZENTALIS PHARMACEUTICALS, INC. Date: January 29, 2025 By: /s/ Julie Eastland Julie Eastland President and Chief Executive Officer

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