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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):
May 13, 2026
| 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
Not Applicable
(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 8.01 Other Events.
On
May 13, 2026, Onconetix, Inc. issued a press release on the first quarter operational and clinical progress of its fully-owned Swiss subsidiary,
Proteomedix AG, a developer of Proclarix®, a diagnostic blood test used in combination with prostate-specific antigen to identify
clinically significant prostate cancer. The press release details, among other things, two recently published peer-reviewed papers on
the performance and prognostic value of Proclarix, as well as the initiation of a multi-center clinical study with Labcorp Holdings Inc.
in the U.S. to evaluate Proclarix.
A
copy of the press release is filed as Exhibit 99.1 to this Current Report on Form 8-K.
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 |
| 99.1 |
|
Press Release, dated May 13, 2026. |
| 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.
| |
Onconetix, Inc. |
| |
|
| May 13, 2026 |
By: |
/s/ David Allan White |
| |
Name: |
David Allan White |
| |
Title: |
Chief Executive Officer |
Exhibit 99.1
Onconetix Reports Q1 2026 Progress at Proteomedix
AG, Including Two New Peer-Reviewed
Publications and Initiation of U.S. Validation Study
New Clinical Data Reinforce Proclarix®
Performance in Reducing Overdiagnosis and Unnecessary Biopsies; Multi-Center PRIME Study Initiated in Collaboration with Labcorp; European
Commercial Expansion Advances
CINCINNATI, Ohio, May 13, 2026 (GLOBE NEWSWIRE) — Onconetix,
Inc. (Nasdaq: ONCO) (“Onconetix” or the “Company”) today provided an update on the Q1 2026 operational progress
of its fully-owned Swiss subsidiary, Proteomedix AG (“PMX”), developer of Proclarix®, a CE-IVD certified diagnostic blood
test used in combination with PSA (prostate-specific antigen) to identify clinically significant prostate cancer (“csPCa”).
Prostate cancer is the most frequently diagnosed male cancer in most
countries globally and represents a significant burden to patients and healthcare systems. Proclarix® is designed to support clinicians
in distinguishing clinically significant from clinically insignificant prostate cancer at an early stage, reducing unnecessary biopsies
and overdiagnosis.
New Peer-Reviewed Clinical Publications
Two new peer-reviewed scientific publications from a recent clinical
study conducted in Denmark further reinforce the clinical utility of Proclarix®.
The first paper, by Schiess et al., has been accepted for publication
in BMC Cancer, a renowned open-access oncology research journal. The study evaluated Proclarix® in a cohort of 371 men and demonstrated
its superior performance in ruling out clinically insignificant or absent prostate cancer while maintaining a low risk of missing csPCa.
Proclarix® was shown to significantly reduce overdiagnosis and unnecessary biopsies, outperforming both %fPSA and the ERSPC risk calculator.
The second paper, by Athanasiou et al., has been published in the journal
Cancers (2026, 18, 1348-62). In a cohort of 132 men under active surveillance, the study demonstrated the prognostic value of Proclarix®
and its risk score in predicting the transition of patients from active surveillance to active treatment.
PRIME Study Initiated with Labcorp
To evaluate Proclarix® in the U.S. market and across various ethnicities,
PMX has initiated the PRIME study, a multi-center clinical validation study conducted in collaboration with Labcorp Holdings Inc. The
first participants have been enrolled, and the study is designed to ultimately include up to 500 men.
European Commercial Expansion
PMX continued to advance its commercial presence across Europe during
Q1 2026. In the United Kingdom, Proclarix® is now offered by a patient organization as an additional option within a real-world screening
initiative for early identification of prostate cancer. Close to 100 Proclarix® tests were carried out within this initiative in Q1
2026 alone.
PMX has also identified a collaboration partner in Turkey and continues
its efforts to expand market reach into additional European countries.
About Onconetix, Inc.
Onconetix, Inc. (Nasdaq: ONCO) is a commercial-stage biotechnology
company focused on the research, development, and commercialization of innovative oncology solutions. Onconetix owns Proclarix®, an
in vitro diagnostic test for prostate cancer originally developed by Proteomedix and approved for sale in the European Union under the
IVDR, which it anticipates will be marketed in the U.S. as a lab developed test through its license agreement with Labcorp. For more information,
visit www.onconetix.com.
About Proteomedix AG
Proteomedix AG (PMX) is a fully owned Swiss subsidiary of Onconetix,
Inc. focused on the development and commercialization of innovative diagnostic solutions for prostate cancer. PMX developed Proclarix®,
a CE-IVD certified diagnostic blood test that, when used in combination with PSA, supports the early identification of clinically significant
prostate cancer. PMX is headquartered in Switzerland. For more information, visit www.proteomedix.com.
Forward-Looking Statements
Certain statements in this press release are forward-looking within
the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking
words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and
“intend,” among others. These forward-looking statements are based on Onconetix’s current expectations and actual results
could differ materially. Investors should read the risk factors set forth in Onconetix’s Annual Report on Form 10-K filed with the
SEC on March 13, 2026, and periodic reports filed with the SEC on or after the date thereof. All forward-looking statements are expressly
qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date hereof.
Onconetix does not undertake an obligation to update or revise any forward-looking statement except as required by applicable law.
Investor and Media Contact:
Onconetix, Inc.
201 E. Fifth Street, Suite 1900
Cincinnati, OH 45202
Phone: (513) 620-4101
Email: investors@onconetix.com
