COMPANY:

Onconetix

"Blue Water Biotech, Inc...announced the acquisition of Proteomedix AG, a private, commercial-stage diagnostics oncology company (the 'Transaction'), and introduced a new name for the combined Company: Onconetix, Inc. The Transaction reflects a transformation of the business to one focused on the research, development and commercialization of proprietary science and technologies for therapeutics, diagnostics and services for the treatment of cancer. The acquisition of Proteomedix for all stock consideration provides its shareholders with an initial 19.9% ownership stake of Onconetix....The new focus of Onconetix aligns the business with the market value drivers in oncology and extensive life sciences company-building expertise of its new leadership team under the direction of President and CEO, Dr. Neil J. Campbell."

"Proteomedix...announced that new results evaluating Proclarix® in the diagnostic work-up of prostate cancer at the University Hospital Zurich were published in BJUI Compass...The aim of this work was to evaluate Proclarix, a biomarker test for the detection of relevant PCa, regarding its diagnostic value in all men before biopsy and in men with indeterminate lesions on mpMRI (PI-RADS 3) during work-up for PCa."

"Proteomedix...announced today that it entered into an agreement for Labcorp, a leading global life sciences company, to be the only laboratory to develop and commercialize the Proclarix® Prostate Specific Antigen (PSA) test in the U.S.. Proclarix is performed using the same blood sample as a PSA test, and is designed to help determine the risk of clinically significant prostate cancer for men with an elevated total PSA and a digital rectal examination that indicates elevated prostate volume, but who are not suspected of having cancer. In appropriate cases, the test provides a non-invasive alternative to a prostate biopsy, which can have significant side effects."

"Proteomedix...announced that Proclarix® has been included in the 2023 clinical practice guideline for the early detection of prostate cancer of the American Urology Association (AUA), in partnership with the Society of Urologic Oncology (SUO)."

"Proteomedix...announced that Proclarix® has been included in the 2023 European Association of Urology (EAU) Guidelines for the diagnostic evaluation of prostate cancer."

"Proteomedix...announced that new results evaluating Proclarix® in combination with imaging were published in BJU International...The aim of the study highlighted here was the assessment of the diagnostic performance of Proclarix in combination with mpMRI."

"Proteomedix...announced that is has received IVDR certification for its prostate cancer diagnostic test Proclarix® from TÜV SÜD...The new In Vitro Diagnostic Regulation (IVDR) recently replaced the IVD Directive. Under the IVDR, diagnostic products are categorized under a new system of one of four classifications from class A (low risk) to class D (highest risk). Proclarix as class C was assessed by TÜV SÜD for conformity resulting in IVDR certification."

"Immunovia AB...announced that it enters into a strategic partnership with Proteomedix to leverage its substantial joint development experience in diagnostic technologies for the detection of cancer. This will enable increased R&D productivity for Immunovia as the Company continues to strengthen its commercial development in the US...The partnership capitalizes on the combined expertise of two leading innovators in proteomics-based diagnostics, who have both launched innovative oncology tests, Immunovia with IMMray™ PanCan-d in the U.S. and Proteomedix with Proclarix® in Europe."