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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): October 31, 2023

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 October 31, 2023, Kintara Therapeutics, Inc. (the “Company”) issued a press release announcing the preliminary topline results of the Global Coalition for Adaptive Research Glioblastoma Adaptive Global Innovative Learning Environment study for VAL-083 (the “GBM AGILE Study”). 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 October 31, 2023, the Company announced that preliminary topline results of the GBM AGILE Study showed that VAL-083 did not perform better than the current standards of care in glioblastoma. The topline results included preliminary safety data for VAL-083 that was similar to that of the current standards of care used to treat glioblastoma. With the GBM AGILE Study outcome, the Company is suspending the development of VAL-083 and turning its focus to its second program, REM-001. In addition to focusing on its REM-001 program, the Company will evaluate a wide range of strategic options aimed at potentially maximizing shareholder value. The Company expects to enroll the first subject in a 15-patient study of REM-001 in cutaneous metastatic breast cancer around the end of calendar year 2023.

 

Item 9.01

Financial Statements and Exhibits.

(d) Exhibits

 

Exhibit No.

Description

99.1

 

Press Release dated October 31, 2023

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: October 31, 2023

By:

/s/ Robert E. Hoffman

Name: Robert E. Hoffman

Title: Chief Executive Officer