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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): March 24, 2025

 

Onconetix, Inc.

(Exact name of registrant as specified in its charter)

 

Delaware   001-41294   83-2262816
(State or other Jurisdiction
of Incorporation)
  (Commission File Number)   (IRS Employer
Identification No.)

 

201 E. Fifth Street, Suite 1900 Cincinnati, Ohio   45202
(Address of Principal Executive Offices)   (Zip Code)

 

Registrant’s telephone number, including area code: (513) 620-4101

 

 

(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, par value $0.00001 per share   ONCO   The Nasdaq Stock Market LLC

 

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 March 24, 2025, the Company issued a press release announcing the new clinical data of Proclarix® that was presented on March 23, 2025 at the 2025 European Association of Urology (EAU), which data further demonstrates the strong clinical performance of Proclarix® in a Danish cohort. As previously announced, an abstract including this clinical data was accepted for presentation at the 2025 European Association of Urology congress taking place between March 21 and March 24, 2025, in Madrid, Spain. A copy of the press release and the abstract is attached hereto as Exhibit 99.1 and Exhibit 99.2, respectively.

 

The information in this Item 7.01 of this Current Report and the Press Release being furnished herewith shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section or Sections 11 and 12(a)(2) of the Securities Act. The information contained in this Item 7.01 and in the Press Release shall not be incorporated by reference into any filing with the SEC made by the Company, whether made before or after the date hereof, regardless of any general incorporation language in such filing.

 

Item 9.01 Exhibits.

 

(d) Exhibits

 

Exhibit
Number
  Description
99.1   Press Release dated March 24, 2025
99.2   Abstract
104  

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

 

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SIGNATURE

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

  Onconetix, Inc.

 

Date: March 24, 2025 By: /s/ Karina M. Fedasz
    Karina M. Fedasz
    Interim Chief Financial Officer

 

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