false000149838200014983822022-06-152022-06-15

 

 

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): June 15, 2022

 

 

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 offices)

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 (17 CFR §230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2).

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 June 15, 2022, Kintara Therapeutics, Inc. (the “Company”) issued a press release announcing that the United States Food and Drug Administration (the “FDA”) has granted Fast Track Designation (“FTD”) to VAL-083 for the treatment of patients with newly-diagnosed unmethylated glioblastoma. A copy of the Company’s 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 June 15, 2022, the Company announced that the FDA has granted FTD to VAL-083 for the treatment of patients with newly-diagnosed unmethylated glioblastoma.

 

Fast Track is a process designed to facilitate the development, and expedite the review of drugs to treat serious conditions and fill an unmet medical need. Some of the significant benefits of FTD include:

 

•
Enhanced access to the FDA, including opportunities for more frequent meetings and written consultation throughout the remaining development of VAL-083.
•
Drugs with FTD are eligible to apply for Accelerated Approval and Priority Review at the time of a New Drug Application (“NDA”) submission, which may result in faster product approval.
•
FTD also allows for 'rolling review', whereby the Company may submit completed sections of the VAL-083 NDA as they become available, rather than at the end of development.

 

Item 9.01 Financial Statements and Exhibits.

 

(d) Exhibits.

 

 

 

Exhibit No.

 

Description

 

 

99.1

 

Press Release dated June 15, 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.

 

 

 

 

 

 

 

 

KINTARA THERAPEUTICS, INC.

 

 

 

Date: June 16, 2022

 

By:

 

/s/ Scott Praill

 

 

 

 

Name: Scott Praill

 

 

 

 

Title: Chief Financial Officer

 

 

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