# EDGAR Filing Document

**Accession Number:** 0001782107
**File Stem:** 0001213900-25-119898
**Filing Date:** 2025-12
**Character Count:** 13800
**Document Hash:** 4cf069b4ed4241ac539aa46b516c529d
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001213900-25-119898.hdr.sgml**: 20251210

**ACCESSION NUMBER**: 0001213900-25-119898

**CONFORMED SUBMISSION TYPE**: 8-K

**PUBLIC DOCUMENT COUNT**: 13

**CONFORMED PERIOD OF REPORT**: 20251206

**ITEM INFORMATION**: Entry into a Material Definitive Agreement

**ITEM INFORMATION**: Financial Statements and Exhibits

**FILED AS OF DATE**: 20251210

**DATE AS OF CHANGE**: 20251210

**FILER**: 

**COMPANY DATA:**
- **COMPANY CONFORMED NAME:** Onconetix, Inc.
- **CENTRAL INDEX KEY:** 0001782107
- **STANDARD INDUSTRIAL CLASSIFICATION:** PHARMACEUTICAL PREPARATIONS [2834]
- **ORGANIZATION NAME:** 03 Life Sciences
- **EIN:** 000000000
- **STATE OF INCORPORATION:** DE
- **FISCAL YEAR END:** 1231

**FILING VALUES:**
- **FORM TYPE:** 8-K
- **SEC ACT:** 1934 Act
- **SEC FILE NUMBER:** 001-41294
- **FILM NUMBER:** 251560989

**BUSINESS ADDRESS:**
- **STREET 1:** 201 E. FIFTH STREET
- **STREET 2:** SUITE 1900
- **CITY:** CINCINNATI
- **STATE:** OH
- **ZIP:** 45202
- **BUSINESS PHONE:** 513-620-4101

**MAIL ADDRESS:**
- **STREET 1:** 201 E. FIFTH STREET
- **STREET 2:** SUITE 1900
- **CITY:** CINCINNATI
- **STATE:** OH
- **ZIP:** 45202

**FORMER COMPANY:**
- **FORMER CONFORMED NAME:** Blue Water Biotech, Inc.
- **DATE OF NAME CHANGE:** 20230424

**FORMER COMPANY:**
- **FORMER CONFORMED NAME:** Blue Water Vaccines Inc.
- **DATE OF NAME CHANGE:** 20190710

?xml version='1.0' encoding='ASCII'?

**UNITED STATES**

**SECURITIES AND EXCHANGE COMMISSION**

**WASHINGTON, DC 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): December 6, 2025**

---

| |
|:---|
| **Onconetix, Inc.** |
| **(Exact name of registrant as specified in its charter)** |

---

---

| | | |
|:---|:---|:---|
| **Delaware** | **001-41294** | **83-2262816** |
| (State or other jurisdiction<br> of incorporation) | (Commission File Number) | (IRS Employer <br> Identification No.) |

---

---

| | |
|:---|:---|
| **201 E. Fifth Street, Suite 1900 <br> Cincinnati, Ohio** | **45202** |
| **(Address of principal executive offices)** | **(Zip Code)** |

---

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

**<u>Not Applicable</u>**

(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<br> 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 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 not use or disclose such results to any third party without Labcorp's prior consent.

The foregoing descriptions are qualified in their entirety by reference to the Amendment, which is filed herewith as Exhibit 10.1 2 hereto and is incorporated by reference herein.

**Item 9.01 Financial Statements and Exhibits.**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(d) <u>Exhibits</u>

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#](ea026905201ex10-1_onconetix.htm) |
| 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.

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

---

## Exhibit 10.1

**Exhibit 10.1**

**[\*\*\*] Certain information in this document has been excluded pursuant to Regulation S-K, Item 601(b)(10). Such excluded information is not material and would likely cause competitive harm to the registrant if publicly disclosed.**

**FIRST AMENDMENT TO LICENSE AGREEMENT**

This FIRST AMENDMENT TO LICENSE AGREEMENT (this "<u>Amendment</u>") is made and shall be effective as of the date of the last signature by the parties below (the "<u>Amendment Effective Date</u>") by and between Proteomedix AG, a Swiss company ("<u>Proteomedix</u>"), and Laboratory Corporation of America Holdings, a Delaware Corporation ("<u>Labcorp</u>").

WHEREAS, Proteomedix and Labcorp are parties to that certain License Agreement dated March 27, 2023 (the "<u>Agreement</u>"); and

WHEREAS, the parties desire to amend the Agreement as set forth in this Amendment.

NOW, THEREFORE, in consideration of the foregoing recitals and the mutual covenants set forth herein and other good and valuable consideration, the receipt, adequacy, and sufficiency of which are hereby acknowledged, the parties hereby agree as follows:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1. <u>Amendment to Section 5.2</u>. Section 5.2 of the Agreement is hereby amended by deleting the last sentence thereof and replacing it with the following:

"Once each Clinical Study is completed, Labcorp will provide Proteomedix with the results of the Clinical Study; provided, however, that Proteomedix will not use such results with a third party without Labcorp's prior written consent or disclose such results to a third party without Labcorp's prior written consent."

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2. <u>Addition of Section 5.3</u>. Section 5 of the Agreement is hereby amended to add the following:

"5.3 <u>PRIME Study</u>. In addition to the Clinical Studies and Subsequent Clinical Study described herein, Labcorp shall also use commercially reasonable efforts to complete an additional study known as the "**P**rostate Cancer **R**isk Identification in a **M**ulti-**E**thnic Cohort: a prospective US-based multi-center validation study of Proclarix (PRIME Study)" described in the preliminary version of the clinical protocol synopsis attached as <u>Exhibit</u> C, which clinical protocol synopsis may be updated by the mutual agreement of Labcorp and Proteomedix (the "<u>PRIME Study</u>"). Proteomedix shall pay Labcorp [\*\*\*] as compensation for the performance of the PRIME Study ("<u>PRIME Study Fees</u>") upon achievement of milestones as set forth below. Proteomedix shall provide Labcorp with all reagents and consumables necessary to perform and complete the PRIME Study at Proteomedix's sole cost and expense and at no charge to Labcorp. In addition, Proteomedix hereby acknowledges and agrees that the risk calculator referenced in the PRIME Study protocol is included within the scope of the Licensed IP and the license granted to Labcorp and its Affiliates under Section 2.1 of this Agreement; provided, however that Labcorp shall have no obligation to pay any royalties or milestone payments based upon its and its Affiliates' use of the risk calculator in performance of the PRIME Study.

Labcorp may elect, in its discretion, to conduct an intermediate readout of the results of the PRIME Study prior to completion. If so, Labcorp will notify Proteomedix and disclose and discuss the findings of the readout.

Labcorp shall invoice Proteomedix based upon milestones as outlined below.

---

| | | |
|:---|:---|:---|
| **Milestone** | **Amount** | **Total** |
| Amendment Effective Date | [\*\*\*] | [\*\*\*] |
| [\*\*\*] enrolled subject | [\*\*\*] | [\*\*\*] |
| [\*\*\*] enrolled subject | [\*\*\*] | [\*\*\*] |
| [\*\*\*] enrolled subject | [\*\*\*] | [\*\*\*] |
| [\*\*\*] enrolled subject | [\*\*\*] | [\*\*\*] |
| [\*\*\*] enrolled subject | [\*\*\*] | [\*\*\*] |

---

In the event that the PRIME Study is discontinued prior to enrollment of [\*\*\*] subjects, Proteomedix shall pay Labcorp [\*\*\*] per enrolled subject in excess of the tier for which a milestone payment was most recently paid. *For example, if the PRIME Study is discontinued at* [\*\*\*] *enrolled subjects, Proteomedix would pay Labcorp an additional* [\*\*\*] *(*[\*\*\*] *subjects \** [\*\*\*]*) in lieu of the* [\*\*\*] *milestone payment that would have been payable upon enrollment of the* [\*\*\*] *subject. In such example, the total PRIME Study Fees would be* [\*\*\*] *(plus pass-through fees described in the following paragraph, if any).*

Payment shall be due within thirty (30) days of the date of each invoice."

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;3. <u>Exhibit C</u>. Exhibit C is added to the Agreement and attached to this Amendment.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;4. <u>Agreement Confirmed</u>. Except as set forth in this Amendment, the Agreement is hereby confirmed and shall remain in full force and effect. All capitalized terms used herein but not otherwise defined will have the meaning attributed to such terms in the Agreement.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;5. <u>Execution</u>. This Amendment may be executed in any number of counterparts, each of which shall be an original and all of which, when taken together, shall constitute one agreement. Delivery of an executed counterpart of a signature page of this Amendment by facsimile transmission or e-mail shall be deemed effective delivery of a manually executed counterpart of this Amendment.

***(Signatures appear on the following page.)***

 ****

IN WITNESS WHEREOF, the parties have executed this Amendment as of the Amendment Effective Date.

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| | | | |
|:---|:---|:---|:---|
| **PROTEOMEDIX AG** | **PROTEOMEDIX AG** | **LABORATORY CORPORATION OF AMERICA HOLDINGS** | **LABORATORY CORPORATION OF AMERICA HOLDINGS** |
| By: | /s/ Beat Rheiner, PhD | By: | /s/ Marcia Eisenberg |
| Name: | Beat Rheiner, PhD | Name: | Marcia T. Eisenberg, PhD |
| Title: | CEO | Title: | CSO and SrVP |
| Date: | 12/6/25 | Date: | 12/6/25 |
| By: | /s/ Thomas Meier, PhD |  |  |
| Name: | Thomas Meier, PhD |  |  |
| Title: | Chairman |  |  |
| Date: | 12/6/25 |  |  |

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<u> </u>

**<u>EXHIBIT C</u>**

**<u>PRIME STUDY</u>**

[\*\*\*]