Onconetix, Inc.

We are a commercial stage biotechnology company focused on the research, development, and commercialization of innovative solutions for men's health and oncology. Through our acquisition of Proteomedix, which closed on December 15, 2023, we own Proclarix, an in vitro diagnostic test for prostate cancer. Proclarix was originally developed by Proteomedix and is approved for sale in the European Union under the In Vitro Diagnostic Regulation ("IVDR"). We anticipate Proclarix will be marketed in the U.S. as a lab developed test through our license agreement with LabCorp. Since our inception in October 2018 until April 2023, we focused on research and development, preclinical studies, manufacturing, hiring personnel, acquiring and developing technology, organizing and staffing the company, business planning, establishing our intellectual property portfolio, and raising capital. We previously acquired ENTADFI, an FDA-approved, once daily pill combining finasteride and tadalafil for the treatment of BPH, a disorder of the prostate. However, due to the time and resources needed for commercialization and the Company's cash runway and indebtedness, we abandoned commercialization of ENTADFI and held no remaining inventory as of December 31, 2025. As part of cost reduction efforts, we terminated three employees involved with the ENTADFI program, effective April 30, 2024, with these individuals continuing to assist on an as-needed, consulting basis. At June 30, 2024, the ENTADFI assets were fully impaired. We are currently focusing our efforts on commercializing Proclarix, which is an easy-to-use next generation protein-based blood test that can be done with the same sample as a patient's regular Prostate-Specific Antigen ("PSA") test.