Onconetix, Inc. is a commercial stage biotechnology company engaged in the research, development, and commercialization of diagnostic and therapeutic products for men's health and oncology. The company's primary asset is Proclarix, an in vitro diagnostic test for prostate cancer that measures thrombospondin 1 and cathepsin D biomarkers and generates a risk score to aid biopsy decisions. Proclarix received CE marking under the European In Vitro Diagnostic Directive on January 31, 2019 and subsequently obtained CE marking under the In Vitro Diagnostic Regulation on October 7, 2022, allowing sale in the European Union, the United Kingdom and Switzerland. Onconetix previously acquired the therapeutic product ENTADFI, an FDA approved once daily pill combining finasteride and tadalafil for benign prostatic hyperplasia, but abandoned its commercialization due to cash constraints and no longer holds inventory of that product. The company is headquartered in Cincinnati, Ohio and operates through its wholly owned subsidiary Proteomedix, which holds the Proclarix intellectual property and related know-how. Proclarix is designed for use in men with total PSA levels between 2.0 and 10.0 ng/mL, a normal digital rectal exam and a prostate volume of at least 35 mL, targeting the population where biopsy decisions are most uncertain.
Onconetix generates revenue mainly from the sale of Proclarix tests to diagnostic laboratories and healthcare providers in Europe, where patients typically pay out of pocket because the test is not currently reimbursed by public or private payers. The company also expects future revenue from the United States under an exclusive license agreement with LabCorp, which will develop and commercialize Proclarix as a lab developed test for the U. S. market. In 2025, Proclarix sales totaled $23,091, reflecting early stage market adoption in selected European laboratories. As of December 31, 2025, Onconetix reported cash of approximately $5.2 million, a working capital deficit of about $3.1 million and an accumulated deficit of roughly $131.2 million. During the year ended December 31, 2025, the company used approximately $9.7 million in cash for operating activities. To support near term operations, Onconetix completed Series D and Series E private placements in September and October 2025, raising aggregate net proceeds of approximately $15.5 million. The company continues to rely on external financing to fund product development, commercialization efforts and general corporate expenses until it can achieve sustainable revenue streams. The company's cash runway has been supplemented by the proceeds from the PIPE financings, which are intended to support operations for the next twelve months while it pursues regulatory clearance and commercial scale up of Proclarix in the United States.
Onconetix positions Proclarix as a blood based immunoassay test that helps clinicians determine whether a prostate biopsy is warranted for men with elevated prostate specific antigen levels in the diagnostic grey zone. The assay uses two enzyme linked immunosorbent assays to quantify thrombospondin 1 and cathepsin D, which are combined with age and total and free PSA values in a proprietary algorithm to produce a risk score. Clinical validation studies have demonstrated that Proclarix can reduce unnecessary biopsies by approximately 43% compared with standard PSA based approaches, while maintaining a sensitivity above 90% and a negative predictive value exceeding 90% for clinically significant prostate cancer. In magnetic resonance imaging guided biopsy settings, the test's sensitivity rises to 97% and the negative predictive value reaches 96%. Competitors in the prostate cancer risk assessment market include the percent free PSA test, the 4Kscore, the phi score and the Stockholm3 test, which generally offer more modest improvements in specificity and predictive value. The worldwide in vitro diagnostic market was valued at approximately $109 billion in 2025, with prostate cancer representing a significant segment due to high incidence and ongoing screening practices. Onconetix believes its competitive advantages derive from the test's blood based nature, which eliminates the need for invasive procedures such as prostate massage, its high reproducibility and stability for shipment at ambient temperature, its compatibility with routine laboratory equipment using enzyme linked immunosorbent assay technology, its ease of automation and fast turnaround time, its objective result generation that is independent of operator variability and its foundation in genetics guided biomarker discovery linked to the PI3K/PTEN pathway. Additionally, Proclarix is classified as a class C in vitro diagnostic device under the European In Vitro Diagnostic Regulation and is manufactured under an ISO 13485:2016 certified quality management system, reinforcing its regulatory compliance and analytical reliability.
The company sells Proclarix to diagnostic laboratories, hospitals and clinics across Europe, with established pilot programs in Switzerland, Germany, Italy and the United Kingdom where the test is offered to urologists and general practitioners as an aid in prostate cancer triage. In these markets, patients typically bear the cost of the test directly because reimbursement pathways are not yet in place. In the United States, LabCorp holds an exclusive license to develop and commercialize Proclarix, positioning it as the primary partner for future U. S. market access and enabling the test to be offered through LabCorp's extensive network of laboratories and patient service centers. Onconetix has also entered into licensing discussions with Immunovia AB relating to pancreatic cancer biomarker applications, although those arrangements are separate from its core prostate cancer diagnostic business. The ultimate end users of Proclarix are patients undergoing prostate cancer evaluation, who benefit from a non invasive blood test that can help avoid unnecessary biopsies and associated complications. By providing an objective risk score, Proclarix aims to reduce patient anxiety, lower healthcare system costs associated with unnecessary biopsies and improve overall diagnostic pathway efficiency.