Zentalis Pharmaceuticals (ZNTL) 8-K Zentalis Pharmaceuticals Announces Overview of Clinical and Preclinical Data Presented at AACR

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

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FORM 8-K

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CURRENT REPORT

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): April 11, 2022

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ZENTALIS PHARMACEUTICALS, INC.

(Exact name of registrant as specified in its charter)   

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Delaware	001-39263	82-3607803
(State or other jurisdiction of incorporation or organization)	(Commission File Number)	(I.R.S. Employer Identification No.)

1359 Broadway, Suite 1710

New York, New York 10018

(Address of principal executive offices) (Zip Code)

(212) 433-3791

(Registrant’s telephone number, include area code)

N/A

(Former Name or Former Address, if Changed Since Last Report)  

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Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) 

☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) 

☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) 

Securities registered pursuant to Section 12(b) of the Act:

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 Global Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Item 7.01 Regulation FD Disclosure.

On April 11, 2022, Zentalis Pharmaceuticals, Inc. (the “Company”) issued a press release announcing interim data from the ongoing Phase 1/2 clinical trial evaluating ZN-c3 as a monotherapy for the treatment of advanced solid tumors, in the uterine serous carcinoma (“USC”) dose expansion cohort of patients receiving a dose of ≥300 once daily, and certain other clinical and preclinical developments. A copy of the press release is furnished as Exhibit 99.1 hereto.

The information contained in Item 7.01 of this Current Report on Form 8-K (including Exhibit 99.1 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 it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly provided by specific reference in such a filing.

Item 8.01. Other Events.

On April 11, 2022, the Company announced interim data from the ongoing Phase 1/2 clinical trial evaluating ZN-c3 as a monotherapy for the treatment of advanced solid tumors, in the USC dose expansion cohort of patients receiving a dose of ≥300 mg once daily. As of the January 21, 2022 data cutoff date (n=11 evaluable), ZN-c3 demonstrated an objective response rate (ORR) of 27.3% and a disease control rate (DCR) of 90.9%. The cohort included one subject who achieved an unconfirmed complete response.

Item 9.01. Financial Statements and Exhibits.

(d) Exhibits

The following Exhibit 99.1 relating to Item 7.01 shall be deemed to be furnished, and not filed:

Exhibit No.	Description
99.1	Press Release issued on April 11, 2022.
104	Cover Page Interactive Data File (embedded within the inline XBRL document).

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: April 11, 2022	By:	/s/ Anthony Y. Sun, M.D.
		Anthony Y. Sun, M.D.
		President and Chief Executive Officer