$ONCO·8-K

Onconetix, Inc. · May 13, 8:35 PM ET

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Onconetix, Inc. 8-K

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Onconetix Inc. Announces Proteomedix Clinical Progress and Labcorp Study

What Happened
On May 13, 2026, Onconetix, Inc. (ONCO) issued a press release (filed on Form 8-K) reporting first‑quarter operational and clinical progress for its fully owned Swiss subsidiary, Proteomedix AG. The release highlights two recently published peer‑reviewed papers on the performance and prognostic value of Proclarix®, a blood test used alongside prostate‑specific antigen (PSA) to identify clinically significant prostate cancer. The company also announced the initiation of a multi‑center clinical study in the United States with Labcorp Holdings, Inc. to evaluate Proclarix.

Key Details

  • Press release dated May 13, 2026 was furnished as Exhibit 99.1 to the 8‑K (filed May 14, 2026).
  • Proteomedix AG is a fully owned Swiss subsidiary of Onconetix.
  • Two peer‑reviewed papers on Proclarix performance and prognostic value were recently published (papers cited in the press release).
  • A multi‑center clinical study with Labcorp in the U.S. has been initiated to evaluate Proclarix’s clinical utility.

Why It Matters
Peer‑reviewed publications strengthen the clinical evidence base for Proclarix, which can help support physician adoption and payer discussions. Launching a U.S. multi‑center study with Labcorp — a large clinical laboratory partner — is an important step toward broader clinical evaluation and potential commercial deployment in the U.S. market. The filing does not include financial results or regulatory approvals; it reports operational and clinical progress that investors may view as milestones in product validation and commercialization planning.

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