Onconetix Inc (NASDAQ: ONCO) is a clinical-stage oncology diagnostics company that commercializes in-vitro diagnostic tests for prostate cancer through its subsidiary Proteomedix. Revenue comes from sales of the Proclarix diagnostic test and, beginning in September 2025, from a licensing agreement with Immunovia that includes IP licensing fees and a 3% royalty on net sales of PancreaSure through December 31, 2032. Total revenue fell 67.7% from $2,524,116 in FY2024 to $815,371 in FY2025, against a loss from operations of $17,856,856 in FY2025. The company recorded $11,512,000 in goodwill impairment in FY2025, following $32,347,000 in goodwill impairment and $10,279,796 in intangibles impairment in FY2024. Proclarix holds CE-mark certification under IVDR as a class C device, audited annually by TÜV SÜD, and carries an exclusive worldwide patent license from ETH Zurich and the State Hospital of St. Gallen covering proprietary biomarkers for prostate cancer diagnosis and monitoring. The company is headquartered in the United States and relies on equity capital markets to fund operations.

Revenue model

Transactional revenue from sales of Proclarix diagnostic tests; IP licensing fees from Immunovia ($300,000 due September 30, 2025 and $300,000 due March 31, 2026, plus $100,000 for materials); 3% royalty on Immunovia net sales of PancreaSure from January 1, 2026 through December 31, 2032 (per 10-K filed 2026-03-13).

Products and services

Proclarix: an in-vitro diagnostic test for prostate cancer management, CE-marked under IVDR as a class C device, ISO 13485:2016 certified, included in European and U.S. clinical guidelines. Proteomedix also produces master cell lines and licenses IP for biomarkers used in Immunovia's PancreaSure pancreatic cancer diagnostic test.

Customers and end markets

Healthcare providers and clinical laboratories in the prostate cancer screening and diagnosis end market. Immunovia is an identified licensing partner and customer as of September 2025. Payors are a target adoption channel for Proclarix.

Value-chain role

Diagnostic test developer and manufacturer. Proteomedix designs, produces, and distributes in-vitro diagnostic reagents and stand-alone software. The company relies on third-party shipping carriers and warehousing providers for test delivery and sample collection kit logistics, and on CROs and CMOs for clinical and manufacturing support.

Geographic exposure

Worldwide patent rights for Proclarix biomarkers, with CE-mark providing market access in Europe. U.S. operations noted. Patent grants in China, Europe, Japan, and the United States (per 10-K filed 2026-03-13). No segment-level geographic revenue breakdown disclosed in the excerpts.

Source: SEC 10-K, filed 2026-03-13

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