Onconetix Inc. filed SEC Form 8-K: Entry into a Material Definitive Agreement, Regulation FD Disclosure, Financial Statements and Exhibits
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Item 1.01. Entry Into a Material Definitive Agreement
On September 17, 2025, Proteomedix AG (“Proteomedix”), a wholly-owned subsidiary of Onconetix, Inc. (the “Company”), entered into a licensing agreement (the “Agreement”) with Immunovia, Inc. (“Immunovia”), a pancreatic cancer diagnostics company based in Lund, Sweden. Under the Agreement, Proteomedix will provide Immunovia with master cell lines required to produce antibodies for three of the five biomarkers used in the PancreaSure test, as well as a license to key intellectual property related to the manufacturing of associated reagents.
In return, Immunovia will make two payments of $300,000 each to Proteomedix, due on September 30, 2025, and March 31, 2026. Additionally, Immunovia will make a $100,000 payment for materials and pay a 3% royalty on net sales of PancreaSure and any other products incorporating the licensed intellectual property from January 1, 2026, through December 31, 2032.
The above description of the Agreement is qualified in its entirety by the text of the Agreement, a copy of which is attached as Exhibit 10.1 to this Current Report on Form 8-K and incorporated by reference herein.
Item 7.01 Regulation FD Disclosure.
On September 22, 2025, the Company issued a press release announcing the License Agreement (the “Press Release”). The Press Release is attached hereto as Exhibit 99.1 and is being furnished herewith.
The information in this Item 7.01 of this Current Report on Form 8-K (the “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 of 1933, as amended. The information contained in this Item 7.01 and in the Press Release attached as Exhibit 99.1 to this Current Report shall not be incorporated by reference into any filing with the Securities and Exchange Commission made by the Company, whether made before or after the date hereof, regardless of any general incorporation language in such filing.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
The following exhibits are being filed or furnished, as applicable, with this Current Report on Form 8-K:
| Exhibit No. | Description | |
| 10.1+ | License Agreement, dated September 17, 2025, by and between Immunovia AB and Proteomedix AG | |
| 99.1 | Press Release, dated September 22, 2025 | |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document). |
| + | Certain schedules, exhibits and similar attachments have been omitted pursuant to Item 601(a)(5) of Regulation S-K. ONCO will provide a copy of such omitted materials to the Securities and Exchange Commission or its staff upon request. |
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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.
| Onconetix, Inc. | ||
| September 22, 2025 | By: | /s/ Karina M. Fedasz |
| Name: | Karina M. Fedasz | |
| Title: | Interim Chief Executive Officer and Interim Chief Financial Officer | |
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