Onconetix, Inc. Files Material Definitive Agreement

Ticker: ONCO · Form: 8-K · Filed: 2025-12-10T00:00:00.000Z

Sentiment: neutral

Topics: material-agreement, pharmaceuticals

TL;DR

Onconetix signed a big deal on Dec 6th, filing it today. Big news for pharma prep sector.

AI Summary

Onconetix, Inc. (formerly Blue Water Biotech, Inc.) entered into a material definitive agreement on December 6, 2025. The company, incorporated in Delaware with its principal executive offices in Cincinnati, Ohio, filed this 8-K report on December 10, 2025. The filing pertains to the company's pharmaceutical preparations sector.

Why It Matters

This filing indicates a significant new agreement for Onconetix, Inc., which could impact its future operations and financial performance in the pharmaceutical preparations industry.

Risk Assessment

Risk Level: medium — Material definitive agreements can introduce significant opportunities or risks depending on their terms, which are not detailed in this summary.

Key Players & Entities

FAQ

What is the nature of the material definitive agreement entered into by Onconetix, Inc.?

The filing states that Onconetix, Inc. entered into a material definitive agreement on December 6, 2025, but the specific details of the agreement are not provided in this summary.

When was this 8-K filing submitted to the SEC?

This 8-K filing was submitted on December 10, 2025.

What was Onconetix, Inc.'s former name?

Onconetix, Inc.'s former name was Blue Water Biotech, Inc.

Where are Onconetix, Inc.'s principal executive offices located?

Onconetix, Inc.'s principal executive offices are located at 201 E. Fifth Street, Suite 1900, Cincinnati, Ohio 45202.

What is Onconetix, Inc.'s Standard Industrial Classification (SIC) code?

Onconetix, Inc.'s Standard Industrial Classification (SIC) code is 2834, which corresponds to Pharmaceutical Preparations.

Filing Stats: 827 words · 3 min read · ~3 pages · Grade level 13.1 · Accepted 2025-12-10 09:28:02

Key Financial Figures

Filing Documents

01. Entry Into a Material Definitive Agreement

Item 1.01. Entry Into a Material Definitive Agreement On December 6, 2025, Proteomedix AG, a Swiss Company ("Proteomedix"), a wholly-owned subsiairy of Onconetix, Inc. (the "Company"), entered into an amendment (the "Amendment") of the license agreement with Laboratory Corporation of America Holdings ("Labcorp") dated as of March 27, 2023, by and between the Company and Labcorp (the "Agreement"), pursuant to which Labcorp has the exclusive right to develop and commercialize Proclarix and other products developed by Labcorp using Proteomedix's intellectual property covered by the license in the United States (the "Licensed Products"). Pursuant to the Agreement, Labcorp is obligated to pay royalties on the net sales of any Licensed Products, as well as certain milestone payments. The Amendment provides for a new validation study to be conducted by Labcorp for Proclarix, titled Prostate Cancer Risk Identification in a Multi-Ethnic Cohort: A Prospective U.S.-Based Multi-Center Validation Study of Proclarix (the "PRIME Study"). Pursuant to the Amendment, Labcorp will not be required to pay any royalties or milestone payments in connection with its use of the risk calculator for purposes of the PRIME Study. The Company will compensate Labcorp with specified milestone-based payments for conducting the PRIME Study of up to $300,000 in the aggregate and will bear all associated costs and expenses. Mid-five figure milestone payments will be made as subjects are enrolled, commencing on the effective date of the PRIME Study and to be paid for every additional batch of subjects enrolled. If the final milestone tier is not reached, the Company must pay Labcorp a fixed amount per subject enrolled beyond the last milestone tier that was paid. All payments are due within thirty (30) days of each invoice. Pursuant to the Amendment, Labcorp is also required to provide the Company with the results of each clinical study conducted by Labcorp upon completion; however, the Company may

01 Financial Statements and Exhibits

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 First Amendment to License Agreement between Proteomedix AG and Laboratory Corporation of America Holdings, dated December 6, 2025# 104 Cover Page Interactive Data File (embedded within the Inline XBRL document). # Certain portions of this exhibit (indicated by "[***]" have been omitted pursuant to Item 601(b)(10)(iv) of Regulation S-K as the Company has determined they (1) are not material and (2) are the type that the Company treats as private or confidential. The Company hereby agrees to furnish a copy of any omitted portion to the SEC upon request. 1

SIGNATURES

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. December 10, 2025 By: /s/ Karina M. Fedasz Name: Karina M. Fedasz Title: Interim Chief Executive Officer and Interim Chief Financial Officer 2

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