aibioOnconetix reports Q1 2026 progress at Proteomedix
Tickers ONCO
The Swiss unit added two peer-reviewed papers, began enrolling in a U.S. validation study with Labcorp and kept expanding sales in Europe. The release does not report quarterly revenue or cash.
Key facts
- Company
- Oncopeptides AB (OMXSTO: ONCO)
- News type
- Company Updates
- Primary source
- Onconetix, Inc. 8-K (2026-05-14)
Onconetix, Inc. (Nasdaq: ONCO) reported on May 13, 2026 on operational progress at Proteomedix AG, its fully owned Swiss subsidiary. The company filed the press release with the SEC as Exhibit 99.1 to a Form 8-K on May 14, 2026. The update covered two new peer-reviewed publications, the start of a U.S. validation study with Labcorp, and continued commercial expansion in Europe for Proclarix, a blood test for prostate cancer that Proteomedix develops. The release does not report quarterly revenue or cash.
Two new publications
Proteomedix reported two new peer-reviewed scientific papers from a recent clinical study conducted in Denmark. The first, by Schiess et al., has been accepted for publication in BMC Cancer. The study evaluated Proclarix in a cohort of 371 men and, according to the release, showed superior performance in ruling out clinically insignificant or absent prostate cancer while keeping a low risk of missing clinically significant cancer. The release says the test significantly reduced overdiagnosis and unnecessary biopsies, outperforming both %fPSA and the ERSPC risk calculator. The release gives no sensitivity, specificity or p-values, and "significantly" is the company's word.
The second paper, by Athanasiou et al., has been published in the journal Cancers. In a cohort of 132 men under active surveillance, the study examined the prognostic value of Proclarix and its risk score in predicting the transition of patients from active surveillance to active treatment.
The PRIME study
Proteomedix has started the PRIME study, a multi-center clinical validation study conducted in collaboration with Labcorp Holdings Inc. The purpose is to evaluate Proclarix in the U.S. market and across various ethnicities. The first participants have been enrolled, and the study is designed to ultimately include up to 500 men.
The annual report says Onconetix anticipates that Proclarix will be marketed in the United States as a lab developed test through its license agreement with LabCorp. The same report says the company will perform product validation studies in connection with that license.
European sales
In the United Kingdom, a patient organization now offers Proclarix as an additional option within a real-world screening initiative for early identification of prostate cancer. The release says close to 100 Proclarix tests were carried out within this initiative in the first quarter of 2026 alone. Proteomedix has also identified a collaboration partner in Turkey and continues its efforts to expand market reach into additional European countries.
The product and the company
Onconetix describes itself in its annual report as a commercial stage biotechnology company focused on the research, development and commercialization of innovative solutions for men's health and oncology. Through its acquisition of Proteomedix, which closed on December 15, 2023, it owns Proclarix, an in vitro diagnostic test for prostate cancer. The test is approved for sale in the European Union under the In Vitro Diagnostic Regulation and carries the CE mark.
The report also says the company abandoned commercialization of ENTADFI, an FDA-approved pill for the treatment of BPH that it acquired in April 2023. It held no remaining inventory of that product as of December 31, 2025. Onconetix has no internal manufacturing capabilities for Proclarix and relies on third parties, whose main suppliers are single-source suppliers.
Financial position
SEC XBRL data reports revenue of $815,371 for the fiscal year ended December 31, 2025, compared with $2.5 million for 2024. Net loss was $14.0 million for 2025 and $58.7 million for 2024. Cash from operations was negative $9.7 million in 2025 and negative $10.5 million in 2024.
What the progress does not show
The annual report says Onconetix expects growing revenues from Proclarix in 2026 and beyond, but 2025 revenue fell to $815,371 from $2.5 million, and close to 100 tests in a UK screening initiative is a small base. The company also expects expenses to rise as it commercializes the test, hires staff and runs validation studies. The PRIME study has only enrolled its first participants, so no U.S. data exist yet. Cash used in operations was $9.7 million in 2025, and the release gives no current cash balance to set against it.