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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 OR 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): February 12, 2024

KINTARA THERAPEUTICS, INC.

(Exact name of registrant as specified in its charter)

 

 

 

 

 

Nevada

 

001-37823

 

99-0360497

(State or other jurisdiction

of incorporation)

 

(Commission

File Number)

 

(IRS Employer

Identification No.)

9920 Pacific Heights Blvd, Suite 150

San Diego, CA

92121

(Address of principal executive office)

(Zip Code)

Registrant’s telephone number, including area code: (858) 350-4364

N/A

(Former name or former address, if changed since last report.)

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

 

KTRA

 

The Nasdaq Capital 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.

On February 12, 2024, Kintara Therapeutics, Inc. (the “Company”) issued a press release announcing the initiation of a REM-001 15-patient clinical trial in cutaneous metastatic breast cancer (“CMBC”) patients. A copy of the press release is attached hereto as Exhibit 99.1.

 

The information in this Current Report on Form 8-K under Item 7.01, including the information contained in Exhibit 99.1, is being furnished to the Securities and Exchange Commission, and shall not be deemed to be “filed” for the 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, and shall not be deemed to be incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by a specific reference in such filing.

 

Item 8.01 Other Events.

 

On February 12, 2024, the Company announced the initiation of a REM-001 15-patient clinical trial in CMBC patients. The open label 15-patient study in CMBC patients is evaluating REM-001, a second-generation photodynamic therapy photosensitizer agent, and is designed to test the 0.8 mg dose as well as optimize the study design in advance of a Phase 3 trial initiation. The primary endpoint in the study is Best Overall Objective Response Rate (complete response or partial response) of the target treatment fields at any time from treatment up to, and including, week 24.

 

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits

Exhibit No.

 

Description

99.1

Press Release dated February 12, 2024

104

 

Cover Page Interactive Data File (embedded within the Inline XBRL document)


 


SIGNATURE

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.

 

 

 

 

 

 

 

 

 

 

 

 

KINTARA THERAPEUTICS, INC.

 

 

 

Date: February 12, 2024

 

By:

 

/s/ Robert E. Hoffman

 

 

 

 

Name: Robert E. Hoffman

 

 

 

 

Title: Chief Executive Officer